четверг, 27 октября 2011 г.

Burn Patients Need More Help Coping With Depression

A new study reveals the full extent of psychological problems among people who have spent years recovering from serious burns. About half of those surveyed showed signs of clinical depression, with women being most vulnerable.


While the study findings may not be surprising, specialists are calling them a valuable tool that could spur burn centers to devote more resources to mental healing.


"In addition to looking at whether we can fix this or alter that through plastic surgery, we also need to screen people for depression," said lead author Brett Thombs, who worked on the study at Johns Hopkins University. He now serves as an assistant professor of psychiatry at McGill University in Canada.


Thomas and colleagues surveyed 224 Johns Hopkins patients who were undergoing reconstruction surgery after being burned. On average, the patients suffered burns about seven years earlier.


The findings appear in the January/February issue of the journal General Hospital Psychiatry.


Forty-six percent of those surveyed showed signs of mild, moderate or serious depression. Women and those most concerned about their body images were most likely to be depressed.


It's normal for burn victims to have trouble adjusting to their condition, Thombs said. "I don't think anyone would go through a burn without being horribly sad. It's a very tough adjustment to make."


But some remain depressed and don't recover, failing to move "through a course of grief and be able to pick themselves up and find their way on their own," he said. "They need help of some kind."


There are effective ways to help burn victims who feel ostracized, said Leora Bowden, a clinical social worker who works with burn patients at the University of Michigan. With the help of treatments like cognitive therapy aimed at changing thought patterns patients can "improve their ability to function and their ability to feel better about themselves, both of which are equally important," she said.


It isn't possible to change society's reaction to disfigured people, said John Findley, psychiatrist for the burn and trauma unit at Massachusetts General Hospital. "But we can get (patients) to look at themselves differently, look beyond the skin and see the healthy person that was there before the thermal injury."


General Hospital Psychiatry is a peer-reviewed research journal published bimonthly by Elsevier Science. For information about the journal, contact Wayne Katon, M.D., at (206) 543-7177.


Thombs BD, et al. "Depression in Burn Reconstruction Patients: Symptom Prevalence and Association With Body Image Dissatisfaction and Physical Function. General Hospital Psychiatry 29(1) 2007.


Health Behavior News Service

Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210

Washington, DC 20009

United States

hbns

понедельник, 24 октября 2011 г.

The Most Comprehensive And Accurate Scale For Assessing Depression Is Not The One That Is Most Used

In the current issue of Psychotherapy and Psychosomatics, investigators from the University of Bologna, Copenhagen and Cambridge present data that suggest that the most commonly used scale for assessing depression (the Hamilton Depression Rating Scale) may not be sufficient and another, more comprehensive and accurate, is available.


A comprehensive assessment of the wide spectrum of depressive symptomatology, particularly in its subclinical forms, is lacking in standard rating scales. There is also an emerging need for instruments that can detect small differences in therapeutic studies and have good sensitivity. The purpose of this paper is to review the clinimetric characteristics of Paykel's Clinical Interview for Depression (CID) and to examine the results of the studies in which the interview has been used. Published reports which involved the use of the CID were identified by searching the following electronic databases: Medline, PsychINFO, EMBASE, and Web of Science. A manual search of the literature was also performed. The initial strategies yielded 169 published reports for potential inclusion in the review: 98 are discussed here. The CID has been used extensively in a variety of studies, including descriptive studies, classification by means of factor analysis and cluster analysis, and predictor variables of response to treatment or relapse. The CID has also been used as an outcome measure in several controlled clinical trials and follow-up studies of pharmacotherapy and psychotherapy of affective disorders. It has been shown to be valid and reliable, to discriminate depressives from controls, or different subgroups of depressed patients, and to reflect changes during the course of treatment, particularly when individual symptoms are considered. Evidence from these studies highlights the utility of the CID in clinical research and practice. Its clinimetric characteristics, particularly the broad evaluation of affective symptomatology and the sensitivity to change, make it an instrument of choice in therapeutic trials.


Sources: Journal of Psychotherapy and Psychosomatics, AlphaGalileo Foundation.

пятница, 21 октября 2011 г.

Landmark Results From Depression Efficacy Study To Be Presented By CNS Response At U.S. Psychiatric And Mental Health Congress

CNS Response, Inc. (OTCBB: CNSO) announced that the company will present top-line results from its multi-site clinical trial next week at the U.S. Psychiatric and Mental Health Congress. "Referenced-EEG (rEEG®) Efficacy Compared to Star*D for Patients with Depression Treatment Failure: First Look at Final Results," will be presented by Charles DeBattista, M.D. on Monday, November 2nd, at 3:45 to 6:45 p.m. The conference is being held at the Mandalay Bay South Convention Center in Las Vegas, NV.


Dr. DeBattista is Professor of Psychiatry and Behavioral Health Sciences at Stanford University School of Medicine, and Director of the Depression and Psychopharmacology Clinic at Stanford Medical Center. Dr. DeBattista specializes in psychiatry with special expertise in clinical depression, disorders of excessive somnolence, electroconvulsive therapy, and fatigue.


CNS Response will be conducting an investor conference call and webcast discussing the top-line results on Tuesday, November 3rd, at 8:00 a.m. PST, 11:00 a.m. EST. Details of the conference call will be announced shortly.


Source

CNS Response

вторник, 18 октября 2011 г.

National Campaign Showcases The Importance Of Joining Forces With 'Man's Best Friend' In Overcoming Depression

While many people with depression turn to family and friends for support, research has shown that enlisting the help of an unexpected companion -- a dog -- may also have a positive effect on overall health and well-being(i). As part of her commitment to helping people with the illness, Emmy Award-winning actress, Linda Dano, is leading Support Partners: Canine Companions, a new program that offers practical tips on how to expand support networks by incorporating dogs into the recovery process. The program is sponsored by Eli Lilly and Company and the Psychiatric Service Dog Society.


"Depression is an illness often associated with strong social stigma, causing people to withdraw from their lives, intensifying the emotional symptoms of the illness, like sadness and feelings of worthlessness," said Rakesh Jain, M.D., M.P.H., director of psychiatric drug research, R/D Clinical Research Center, Lake Jackson, Texas. "While a doctor, family and friends should form the basis of any support network, dogs can play an important role by being a constant companion. They can help reduce these emotional symptoms, while possibly helping other symptoms, like fatigue or lack of energy, with daily walks."


Research has shown that there are many potential benefits to having a dog that correlate to areas health-care professionals believe can help people with depression.


-- The majority of pet owners feel their pets are extremely important when
they are sad, lonely or depressed.(ii)



-- Dogs can provide the desirable qualities of a best friend, like
listening, physical contact and empathy.(iii)



-- Half of people with a dog believe that their pet makes a major
difference to their lives, ranking increased exercise and companionship
as the two most important differences.(iv)



-- Talking to dogs is related to greater life satisfaction and better
physical and mental health.(v)


Linda Dano, Support Partners: Canine Companions spokesperson, has personally experienced the benefits a dog can have in helping to manage depression. "As someone who has always been a dog-owner, my Lhasa apsos, Mo and Charlie, became more important to me than ever when I was diagnosed with depression," says Dano. "I started getting help from my physician and support from my friends, and soon realized that my dogs also gave me a sense of comfort, purpose and companionship. Many days when all I wanted was to stay in bed, alone, I knew I had to get up to take care of Mo and Charlie and comfort them as they comforted me."


Support Partners: Canine Companions offers a brochure that provides information about the benefits of dogs, the different levels of support a dog can offer someone with depression and easy, practical ways pet owners can immediately work with their dogs to include them in their support network. The brochure also provides those who are unsure if they have depression information about the illness and how to take the first step of asking for help.















"There are many simple things you can do with your dog if you're depressed that may help you feel better," explains Joan Esnayra, Ph.D., president of the Psychiatric Service Dog Society, a nonprofit organization that works with mental-health consumers who wish to train their dogs to assist with the management of depression. "Taking your dog for a walk can help you get some exercise. Teaching your dog a new trick can give you a sense of accomplishment. Even petting your dog can help with your recovery by relieving stress and anxiety."


About the Support Partners Program


Support Partners: Canine Companions is the newest component of the Support Partners program, a national educational campaign dedicated to people with depression and to those who care about them. Co-sponsored by the National Women's Health Resource Center (NWHRC), the Support Partners program aims to open the lines of communication about the illness and encourages a support- team approach to overcoming depression. Support Partners offers three guidebooks that provide tips for people with depression, and those who care about them, on how to form a support network. Copies of the guidebooks can be obtained by visiting SupportPartnersProgram.


About Depression


Up to 19 million Americans per year are diagnosed with major depressive disorder.(vi),(vii) It can happen to anyone of any age, race or ethnic group(viii); however, women are nearly twice as likely to experience depression as men.(ix) Depression is a serious medical condition with a variety of symptoms, such as sadness, loss of interest, fatigue, changes in appetite or weight, or bodily aches and pains.(x) For some, depression can include thoughts of death or suicide.(xi)


The goal of treatment is to help people with depression feel more like themselves, so they can move forward with their lives. Depression symptoms that don't go away completely can prevent people with depression from getting fully well and may increase the risk of symptoms coming back. Nobody should settle for feeling only slightly better. With the right treatment and support, recovering from depression is possible.


About the Psychiatric Service Dog Society


The Psychiatric Service Dog Society (PSDS) is a 501(c)(3) nonprofit organization dedicated to responsible Psychiatric Service Dog (PSD) education, advocacy, research and training facilitation. It provides essential information for persons disabled by severe mental illness who wish to train a service dog to assist with the management of symptoms. The PSDS consults regularly with mental health-care providers in their efforts to learn more about PSD. The organization also hosts an online community of veteran and new service-dog handlers. The PSDS does not provide or train dogs for individuals. It is an educational and capacity-building organization dedicated to responsible psychiatric service dog community stewardship. Please visit psychdog for more information.


About Lilly


Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at lilly. O-LLY


References


(i) Serpell, J.A. Evidence for long term effects of pet ownership on human health. Pets, Benefits and Practice. Waltham Symposium 20. April 19, 1990.


(ii) The Delta Society. "The Healthy Pleasure of Their Company: Companion Animals and Human Health" by Karen Allen, School of Medicine, State University of New York at Buffalo. Available at deltasociety/TextOnly/AnimalsHealthCompanionComp3.htm. Accessed April 17, 2007.


(iii) Allen, Karen. "Coping with Life Changes & Transitions: The Role of Pet."


(iv) Serpell, J.A. Evidence for long term effects of pet ownership on human health. Pets, Benefits and Practice. Waltham Symposium 20. April 19, 1990.


(v) Allen, Karen. "Coping with Life Changes & Transitions: The Role of Pet."


(vi) Kessler, Ronald et al. "Prevalence, Severity, and Comorbidity of 12- Month DSM-IV Disorders in the National Comorbidity Survey Replication." Arch Gen Psychiatry. June 2005. 62: 617-709.


(vii) United States Census 2000, Population as of April 1, 2000. Available at census/main/www/cen2000.html. Accessed May 10, 2007.


(viii) Depression and Bipolar Support Alliance. About Mood Disorders. Available at: dbsalliance/site/PageServer?pagename=about_MDOverview. Accessed April 24, 2007.


(ix) National Institute of Mental Health. Depression Research at the National Institute of Mental Health: Fact Sheet. Available at nimh.nih/publicat/depression.cfm#ptdep1. Accessed April 4, 2007.


(x) American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.


(xi) American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.

суббота, 15 октября 2011 г.

Mental Disorders Make Up 14% Of Global Disease Burden

Neuropsychiatric disorders (NPDs) make up 14% of the global disease burden, according to The Lancet "Series on Global Mental Health". NPDs contribute more to the total global burden than heart disease, stroke or cancer, because NPDs are so disabling. NPDs include depression, substance and alcohol use disorders, and psychoses.


According to Professor Martin Prince, Institute of Psychiatry, King's College, London, mental illnesses raise the probability of developing and exacerbating a wide range of physical illnesses. Prof. Prince is one of the writers of "No health without mental health", part of a series of six reviews.


Prof. Prince explained that NPDs are common accompaniments of other communicable and non-communicable diseases (NCDs) - they complicate their treatment, are usually linked to poorer outcomes, including a higher death rate for patients. Prince says we need to carry out more research on these links; especially on the potential for mental health interventions to improve patients' physical outcomes.


Not much research has been carried out on the impact of NPDs on physical illnesses in low and middle income countries. 80% of all NCD deaths and 99% of HIV/AIDS deaths happen in low and middle income countries. As mental healthcare budgets in these countries are low, we need to find some way of measuring the impact of neuropsychiatric disorders.


Prof Prince said "Mental health awareness needs to be integrated into all elements of health and social policy, health-system planning, and delivery of primary and secondary general health care."


The following are NPDs:


-- Schizophrenia

-- Depression

-- Anxiety

-- Bipolar Disorder

-- Attention Deficit Hyperactivity Disorder

-- Alzheimer's Disease

-- Obsessive Compulsive Disorder

-- Eating disorders


Neuropsychiatry is a branch of medicine. It deals with mental disorders attributable to diseases of the nervous system.


The Lancet "Series on Global Mental Health"






среда, 12 октября 2011 г.

FDA Strengthens Warning For Pregnant Women Using Paxil After Two Studies Link Use To Fetal Heart Defects

FDA on Thursday issued a public health advisory warning pregnant women and physicians about an increased risk of fetal heart defects from taking GlaxoSmithKline's antidepressant Paxil -- known generically as paroxetine -- during the first three months of pregnancy, the Washington Post reports (Kaufman/Vedantam, Washington Post, 12/9). The warning moves Paxil to Category D, FDA's second-highest category for risk of birth defects. Category D means that either "controlled or observational" studies of pregnant women "have demonstrated a risk to the fetus" (FDA release, 12/8). The advisory is based on preliminary results from two studies, which found that women taking Paxil during the first three months of pregnancy were 1.5 to two times as likely to give birth to an infant with a heart defect as women who took other antidepressants or none at all (Washington Post, 12/9).

Studies, Recommendations
The first study, an evaluation of U.S. health insurer data, found that about 2% of women who took Paxil early in pregnancy gave birth to infants with heart defects, compared to about 1% of all women. The other study, which examined data from about 6,900 infants in Sweden, found that 1.5% of women taking Paxil in their first trimester gave birth to infants with heart defects, compared to 1% of women who took other antidepressants (Richwine, Reuters, 12/8). Most of the heart defects reported in the studies were atrial and ventricular septal defects, or holes in the heart walls, which sometimes can require surgery and sometimes can resolve with no treatment (AP/South Florida Sun-Sentinel, 12/9). For women taking Paxil who plan to become pregnant or are three months pregnant or less, "[h]ealth care professionals should consider discontinuing [the drug] -- and switching to another antidepressant if indicated," FDA said in a release, adding, "In some patients, the benefits of continuing Paxil may be greater than the potential risk to the fetus. FDA is advising health care professionals not to prescribe Paxil in women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate" (FDA release, 12/8). Before Thursday's advisory, Paxil had been classified as a Category C drug for pregnant women, which means comprehensive studies of its effects during pregnancy have not been performed (Kaiser Daily Women's Health Policy Report, 9/28).

Reaction
GSK spokesperson Gaile Renegar said that the studies are examinations of databases and not clinical trials (Reuters, 12/8). She added that the company is studying to see how and why Paxil might be causing any birth defects (Washington Post, 12/9). GSK has worked with FDA to make the labeling changes and to communicate the updated findings for Paxil so physicians and patients can make well-informed treatment decisions," Jack Modell, GSK vice president of clinical psychiatry, said (GSK release, 12/8). Kimberly Yonkers, a psychiatrist at Yale University School of Medicine, also noted the limitations of the two studies, adding, "Depression is still undertreated. Pregnant women in particular are immensely undertreated, and you worry about people being unduly frightened." Robert Temple, FDA's director of medical policy, said, "If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," adding, "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change" (Washington Post, 12/9).

NBC's "Nightly News" on Thursday reported on the advisory. The segment includes comments from Lee Cohen, director of the perinatal and reproductive psychiatry clinical research program at Massachusetts General Hospital (Bazell, "Nightly News," NBC, 12/8). The complete segment is available online in Windows Media.


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.


View drug information on Paxil CR.

воскресенье, 9 октября 2011 г.

Suicide Prevention Group Delivers Much Needed Message To Pennsylvania's Elderly

This month, in recognition of
National Mental Health Month and Older Pennsylvanians Month, Feeling Blue
Suicide Prevention Council (SPC) will offer an important message to senior
citizens through a public service announcement. The public service
announcement developed by Feeling Blue SPC is intended to bring awareness
to the public health problem of depression and to offer hope to older
Pennsylvanians who may be feeling suicidal: You are not alone in your
feelings of depression. There's hope and there's help.



Older adults are the highest risk population in the country, but few
suicide prevention programs target them. Through a grant provided by the
Pennsylvania Department of Health, Feeling Blue SPC has been able to make
this objective possible.



"As a responsible society, we must ensure the mental health and
well-being of our older population," said Department of Health Secretary
Dr. Calvin B. Johnson. "We hope this announcement can help spread the
message that depression is not a 'normal' part of aging and that suicide
can be prevented."



The statistics surrounding elderly suicide are alarming. According to
the National Strategy for Suicide Prevention, a division of the U.S.
Department of Health & Human Services, risk factors for suicide among older
persons differ from those among the young. Elderly people are also more
socially isolated. Additionally, approximately three quarters of the older
adults who die by suicide have visited a physician within one month of
taking their life.



Feeling Blue Suicide Prevention Council (SPC) is a nonprofit
organization dedicated to preventing suicide, reducing the stigma
associated with suicide, and supporting those people affected by depression
or by the loss of a loved one to suicide. They do this through education,
training and linking people with a variety of resources.


Feeling Blue Suicide Prevention Council

feelingblue

четверг, 6 октября 2011 г.

UAB Researchers Assess Psychopathological Symptoms In Pre-School Children

The Unit of Child and Adolescent Psychopathology, part of the UAB Department of Clinical and Health Psychology, is undertaking pioneer research in Catalonia on the prevention and detection of emotional and behavioural disorders among children between the ages of three and six. The results show a high percentage of children in this age group with some kind of psychopathological symptom. According to the researchers, detecting these is vital since at this age children can be treated to prevent psychopathological symptoms appearing at a later stage.



The objective of the research carried out by the Unit is to generate awareness of psychopathologies in pre-school children, particularly in schools and in educational psychologists. The aim is that these not only focus on children with language disorders, developmental delay, etc, but also on the whole of this population, based on the idea that improving prevention is much easier with children of this age group.



This age group is crucial for the future, since 99% of children who do not suffer from any kind of disruptive behaviour do not develop these disorders in later life. By contrast, those who do suffer from disruptive behaviour continue to have the same problem five years later or develop some other kind of disorder.



The concern and the studies focused on this age group are very recent. The researchers have found that many of the problems and disorders found at later stages in life begin during this period of childhood. This is the first time anyone has studied the problem in Catalonia. The geographical location is a very important factor for this kind of study, which is why the data from studies carried out in other countries can only be used as a guide and it is vital to carry out fieldwork at the same location.



The study consists of various field studies that look into the psychopathological disorders in pre-school children from different perspectives: the different ways in which these disorders develop in children living in an urban environment and those living in a rural environment, the appearance of physical symptoms, the development of eating disorders due to psychosocial factors, the difference between parents and teachers in the detection of symptoms of depression, etc.





Contact: Lucas Santos


Universitat Autonoma de Barcelona

понедельник, 3 октября 2011 г.

Controversial Electroconvulsive Therapy Helps Severe Depression, From The Harvard Mental Health Letter

Passing an electric current
through the brain to induce a seizure is not everyone's idea of a
therapeutic procedure. So it's no surprise that electroconvulsive therapy
(ECT) has been controversial. Fears of misuse are common, and efforts to
restrict or abolish the practice have had some success. Yet ECT persists
because it can be a uniquely effective treatment for severe depression and
other mental illnesses, reports the February 2007 issue of the Harvard
Mental Health Letter.


The treatment affects many brain pathways, nerve receptors,
neurotransmitters, and endocrine systems. Before the advent of ECT, drugs
were used for the same purpose, but were less effective and had more
serious side effects.



The most common side effect of ECT is memory loss. Tests show that
memory- both the ability to recall earlier events and the ability to absorb
new knowledge-declines with ECT. Memory usually returns to normal within a
few weeks, but not necessarily for all patients and in all respects. The
way the treatment is done may make a difference. For instance, research
suggests that placing both electrodes on the same side of the head, using
intermittent pulses instead of continuous stimulation, and lowering the
dose of electricity can greatly reduce the risk of memory loss.



"ECT continues to restore the health and sometimes save the lives of
people with the potentially lethal disorders of severe depression, mania,
and acute psychosis. For the patients who suffer most with mood symptoms,
nothing better than ECT has been devised," says Dr. Michael Miller, editor
in chief of the Harvard Mental Health Letter. "That is the most important
reason for its survival through doubts, fears, and political controversy."


Harvard Health Publications

health.harvard

пятница, 30 сентября 2011 г.

Novartis Highlights Strong R&D Pipeline, Plans For Multiple New Product Launches And Novel Projects Moving Into Late-stage Trials

Novartis unveiled today new data on its promising pipeline amid plans for multiple new product approvals and launches over the next two years. Many of these anticipated approvals are for potentially best-in-class medicines that would advance treatment standards for patients with hypertension, diabetes, cancer and other diseases.



Novartis highlighted progress throughout its pipeline, particularly the advance of pharmaceutical compounds to pivotal trials before regulatory submission as well as the development portfolio in the newly created Vaccines and Diagnostics division.



The following compounds are moving into pivotal late-stage trials: FTY720 (fingolimod) for multiple sclerosis, QAB149 (indacaterol) for COPD and asthma, AG0178 (agomelatine) for depression and ABF656 (Albuferon(TM)) for hepatitis C as well as RAD001 (everolimus) for cancer and SOM230 (pasireotide) for Cushing's disease.



"I am pleased that our sustained focus on innovation and drive to address unmet medical needs have enabled us to further strengthen our pipeline and file several new drugs for regulatory review over the past 12 months," said Dr. Daniel Vasella, Chairman and CEO of Novartis.



"Over the next two years we will launch several innovative medicines and continue to invest aggressively in discovery research and development activities and complement our own skills and technologies through attractive collaborations," Dr. Vasella said.



In total, Novartis now has 138 projects in pharmaceutical clinical development. Of these, 94 projects are in confirmatory development (Phase IIb, Phase III or registration with regulatory authorities). A total of 50 are new molecular entities (NMEs), while 88 are life-cycle management projects involving new indications or formulations.[2] More than 20 projects have been added to the pipeline during 2006. Key R&D areas are cardiovascular/metabolic conditions, oncology and neuroscience as well as respiratory and infectious diseases.



Novartis has completed many submissions in 2006 to regulatory authorities for new compounds as well as new indications for medicines already available to patients.



The US and EU regulatory submissions were accelerated and completed ahead of schedule in 2006 for two compounds: Tasigna (nilotinib) as a new treatment option for patients with resistance and/or intolerance to treatment with Gleevec/Glivec for certain forms of chronic myeloid leukemia (CML), and also for Aclasta/Reclast (zoledronic acid) as a once-yearly bisphosphonate infusion for women with postmenopausal osteoporosis.
















US regulatory decisions are also expected for Tekturna (aliskiren), a renin inhibitor for hypertension, and Exforge (valsartan and amlodipine), a single-tablet combination of the two most prescribed hypertension medicines in their respective classes.



Awaiting European Commission approval are Exforge and Lucentis, a new treatment option for patients with the "wet" form of age-related macular degeneration (AMD), after both compounds received positive recommendations in November from the Committee for Medicinal Products for Human Use (CHMP). The Commission generally follows the recommendations of the CHMP and delivers a final decision within two to three months.



A US regulatory decision is also expected in the first half of 2007 for Galvus (vildagliptin) as a once-daily oral treatment for patients with type 2 diabetes. The US Food and Drug Administration (FDA) extended the review period for Galvus by three months from November 2006 after recently available clinical data were submitted to support the proposed dosing and indications as well as complement earlier data on the risk/benefit profile.



Sustained leadership in hypertension


Approvals of Exforge and Tekturna would further strengthen the leadership of Novartis in offering a broad range of treatments for patients with hypertension, complementing the in-market brands Diovan and Lotrel.



High blood pressure - and its consequences - is the world's No. 1 killer, estimated by the American Heart Association to affect one in four adults, or around one billion people globally. Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach target blood pressure levels. Many require two or more medicines to gain control.



Exforge is the first medicine to combine the angiotensin receptor blocker (ARB) valsartan (Diovan) and the calcium channel blocker (CCB) amlodipine besylate. More than 80% of Exforge patients in studies reached their recommended blood pressure goals and also experienced a lower rate of peripheral edema (swelling of the ankles) compared to those taking amlodipine alone.



Tekturna, which was developed in collaboration with Speedel, has shown a strong efficacy profile in hypertension patients. New data presented at the event showed Tekturna demonstrated a statistically significant (p=0.0004) reduction in blood pressure compared to a diuretic (hydrochlorothiazide), while results from this 12-week trial also showed strong efficacy in combination with the same diuretic in obese patients. Tekturna has shown placebo-like safety at the proposed maximum once-daily dose of 300 mg.



In another new study, the combination of Tekturna and Diovan showed a significant additive reduction in blood pressure compared to Diovan alone, with a drop in systolic blood pressure of about 17 mm Hg compared to about 13 mm Hg for either Tekturna or Diovan alone.



Additional data support efficacy and safety of Galvus


Novartis is confident in the efficacy and safety of Galvus and in obtaining US approval for this once-daily oral treatment for patients with type 2 diabetes. Results from recently completed clinical trials are being submitted to the FDA involving an additional 1,000 patient-years of treatment experience.



These data include results from short- and long-term studies for periods of up to two years, both as a monotherapy or in combination with other anti-diabetes medicines. They further support the proposed dosing regimen and indications as well as complement the risk/benefit profile of Galvus. In particular, they provide further evidence confirming data submitted earlier to the FDA showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with type 2 diabetes patients.



New data presented at the event again confirmed the once-daily efficacy of Galvus, while pooled monotherapy data showed a 1.1% reduction in HbA1c (a measure of average blood sugar levels) in initial use by type 2 diabetes patients starting treatment. The results of a 104-week trial continued to show the sustained reduction of 1% in HbA1c seen at 52 weeks, but narrowly missed the primary endpoint of non-inferiority versus metformin. However, Galvus was better tolerated than metformin, particularly with a superior gastrointestinal tolerability profile.



Vaccines pipeline supports existing franchises and explores new fields
Novartis has assembled a strong pipeline of investigational human vaccine projects following the acquisition of Chiron in April 2006, focusing on supporting existing franchises in influenza, meningitis and travel vaccines while exploring new disease areas.



Among new data presented at the event were the positive results of a Phase II trial involving 500 volunteers inoculated with an adjuvanted H5N1 pre-pandemic vaccine. Results showed that various levels mandated by European regulators for seroprotection, seroconversion increase and mean geometric increase of H5N1-specific antibodies were achieved. Novartis announced today that this vaccine has been submitted for European approval for use as a pre-pandemic vaccine to boost the immune system's ability to defend against infections from an H5N1 strain.



The OptaFlu seasonal influenza vaccine, which is based on novel cell culture technology instead of traditional egg-based production, showed in pivotal Phase III data that it was highly capable of producing an immune response ("immunogenic"), at least as strong as the egg-based vaccine Agrippal® for each of the three influenza strains studied. It was also well tolerated, showing no meaningful differences in the safety profile compared to traditional egg-based vaccines. The EU submission was completed in 2006, while the US submission is planned for 2008.


Novartis also announced progress in the development of its conjugate quadrivalent MenACWY vaccine against the A, C, W135 and Y serogroups of Neisseria meningitides, important causes of bacterial meningitis. This devastating disease is estimated to strike about three to five of 100,000 people per year - particularly infants and children. Phase III trials involving 13,000 people started in April 2006, targeting regulatory submission for use in infants, adolescents and adults.



A vaccine for the B serogroup of meningitis B, for which there is currently no effective vaccine, is also in Phase II studies to identify dosing in adolescents, with data expected by the end of 2007.



Productive innovation filling the early-stage pipeline
New discovery approaches at the Novartis Institutes for BioMedical Research (NIBR), which was created four years ago to enhance the Group's long tradition of drug discovery, are contributing novel compounds to clinical development.



The number of new molecular entities in the NIBR portfolio has increased to more than 70 in 2006 (compared to 55 in 2004), driven in part by new target discovery, enhanced structural biology, and rapid growth in the number of biological therapeutic drug candidates. These include antibodies, which now constitute about 25% of the NIBR portfolio.



Selected Pipeline Event highlights
Among projects highlighted at the event were the following:



Aclasta/Reclast (zoledronic acid), a once-yearly bisphosphonate treatment for women with postmenopausal osteoporosis, has been submitted for US and EU approval earlier than planned. This was based on pivotal Phase III data showing that patients taking Aclasta/Reclast experienced a highly significant 70% risk reduction in new spine fractures (p

вторник, 27 сентября 2011 г.

Yerkes Researchers Create Animal Model Of Chronic Stress

In an effort to better understand how chronic stress affects the human body, researchers at the Yerkes National Primate Research Center and the Department of Psychiatry and Behavioral Sciences, Emory University, have created an animal model that shows how chronic stress affects behavior, physiology and reproduction.



Developing the animal model better positions the researchers to understand the neurohormonal causes of such stress and the body reaction in order to develop more effective treatment options for humans. The study is available in the current online edition of Molecular Psychiatry.



According to lead researcher Mark Wilson, PhD, chief of the Division of Psychobiology at Yerkes, "Chronic stress can lead to a number of behavioral changes and physical health problems, including anxiety, depression and infertility."



Via the animal model, the researchers found corticotropin releasing factor (CRF) is a key neurohormone involved in stress response. Wilson explains, "CRF is located in several different brain regions, serving different functions. Its release is important for our ability to adapt to every day stressors and to maintain our physical and emotional health."



In response to stress, CRF levels rise; CRF levels decrease when the stressor no longer is present. Chronic stress, however, increases the length and volume of expression of CRF in areas of the brain associated with fear and emotion, including the amygdala. Such chronic stress changes the body's response, and the resulting increased expression of CRF is thought to be the cause of such health-related stress problems including anxiety, depression and infertility.



To study the importance of CRF, the research team used a viral vector to increase the production of CRF in the amygdala of female rats.



"In our study, rats that continuously were exposed to CRF from this area of the brain experienced anxious and depressive behavior, decreased libido and disrupted ovarian cycles suggesting that persistent release of CRF such as occurs in chronic stress clearly affects multiple body systems," says Wilson. "These behavioral changes are similar to what we see in human females who are exposed to stressors on a daily basis."



Dr. Wilson and his research team next will attempt to learn more about the negative effects of increased CRF by examining actual molecular and cellular changes in specific brain areas targeted by the neurohormone. Knowing how CRF affects the brain positions the researchers to develop better treatment options.







For more than seven decades, the Yerkes National Primate Research Center, Emory University, has been dedicated to conducting essential basic science and translational research to advance scientific understanding and to improve the health and well-being of humans and nonhuman primates. Today, the center, as one of only eight National Institutes of Health-funded national primate research centers, provides leadership, training and resources to foster scientific creativity, collaboration and discoveries. Yerkes-based research is grounded in scientific integrity, expert knowledge, respect for colleagues, an open exchange of ideas and compassionate, quality animal care.



Within the fields of microbiology and immunology, neuroscience, psychobiology and sensory-motor systems, the center's research programs are seeking ways to: develop vaccines for infectious and noninfectious diseases, such as AIDS and Alzheimer's disease; treat cocaine addiction; interpret brain activity through imaging; increase understanding of progressive illnesses such as Parkinson's and Alzheimer's; unlock the secrets of memory; determine behavioral effects of hormone replacement therapy; address vision disorders; and advance knowledge about the evolutionary links between biology and behavior.


суббота, 24 сентября 2011 г.

Study Of Twins Connects Smoking Addiction With Major Depression

Ever wonder why smoking and depression seem to go together? A Saint Louis University School of Public Health researcher finds the connection is genetic.



"Some people with a history of depression may become smokers as a way of self-medicating," said Qiang John Fu, M.D., Ph.D., assistant professor of community health in biostatistics at Saint Louis University School of Public Health. "Some people who are smokers might become depressed when they try to give up cigarettes and can't.



"When I tried to find something to explain this correlation, I discovered the answer lay partly in a person's genes that are associated with conduct disorder, which is extreme rebellious behavior of teens and children," Dr. Fu continued. "My findings are an alternate explanation about why nicotine dependence and major depression go together."



Dr. Fu also found that the genes that increased a person's risk of developing major depression and nicotine addiction are found in those who have conduct disorder, such as stealing, vandalizing, running away from home and fighting. These people are likely to become addicted to other drugs and behave impulsively, he said.



Dr. Fu and his team analyzed 3,360 pairs of middle-aged, predominantly Caucasian twins who served in the military during the Vietnam War.



Slightly more than half were identical twins who had a 100-percent genetic match and about 45 percent were fraternal twins who shared half their genes. Researchers compared the answers from the twins, and used a mathematical model to estimate the genetic and environmental influences on nicotine addiction and major depression.



"Our data showed that both major depression and nicotine dependence were highly genetically correlated with conduct disorder," Dr. Fu said.



The research also helps to explain why smoking seems to run in some families, Dr. Fu said.



"Maybe Dad and Mom have a certain personality, which is why they may be more likely to smoke or to be depressed. That personality trait may be based in their genes," he said.



The research points geneticists in a new direction to determine the influences of a personality trait, Dr. Fu said. In addition, clinicians could use his findings to identify those who are at risk of developing major depression or nicotine addiction.



"When they see people with a history of conduct disorder, they may be able to predict those people who could develop major depression or nicotine dependence," Dr. Fu said.







The research was funded by grants from the National Institutes of Health. It appeared in Twin Research and Human Genetics.



Saint Louis University School of Public Health is one of only 37 fully accredited schools of public health in the United States and the nation's only School of Public Health sponsored by a Jesuit university. It offers master's degrees and doctoral programs in six public health disciplines and a number of joint degrees involving business, law, medicine, nursing and social work. It is home to 12 nationally recognized research centers and draws students from across the United States and from 21 foreign countries.


среда, 21 сентября 2011 г.

Depression Traced to Overactive Brain Circuit

A brain imaging study by the NIH's National Institute of Mental Health (NIMH) has found that an emotion-regulating brain circuit is overactive in people prone to depression - even when they are not depressed. Researchers discovered the abnormality in brains of those whose depressions relapsed when a key brain chemical messenger was experimentally reduced. Even when in remission, most subjects with a history of mood disorder experienced a temporary recurrence of symptoms when their brains were experimentally sapped of tryptophan, the chemical precursor of serotonin, the neurotransmitter that is boosted by antidepressants.


Neither a placebo procedure in patients nor tryptophan depletion in healthy volunteers triggered the mood and brain activity changes. Brain scans revealed that a key emotion-processing circuit was overactive only in patients in remission - whether or not they had re-experienced symptoms - and not in controls. Since the abnormal activity did not reflect mood state, the finding suggests that tryptophan depletion unmasks an inborn trait associated with depression.


Alexander Neumeister, M.D., Dennis Charney, M.D., Wayne Drevets, M.D., NIMH Mood and Anxiety Disorders Program, and colleagues, report on their positron emission tomography (PET) scan study in the August 2004 Archives of General Psychiatry.


The NIMH researchers and others had previously shown that omitting tryptophan from a cocktail of several other essential amino acids washes out the precursor chemical from the blood and brain, depleting serotonin and often triggering symptoms in people with a history of depression - and even in healthy people from depression-prone families. This added to evidence that a genetic predisposition that renders some people vulnerable to inadequate serotonin activity may be at the root of the mood disorder.


The researchers scanned subjects after their blood tryptophan levels were reduced by about three-fourths, using a radioactive tracer (a form of glucose, the brain's fuel) which reveals where the brain is active during a particular experimental condition.


They randomly gave 27 unmedicated depressed patients-in-remission and 19 controls either pills containing seven essential amino acids, such as lysine and valine, or identical-looking placebo pills. Subjects received either the active pills or placebos in repeated trials over several days in a blind, crossover design.


Sixteen (59 percent) of the patients experienced a transient return of symptoms under tryptophan depletion; their mood lifted to normal by the next day. Compared to controls, the patients showed increased brain activity in a circuit coursing through the front and center of the brain (orbitofrontal cortex, thalamus, anterior cingulate, and ventral striatum) - areas involved in regulating emotions and motivation that have been implicated in previous studies of depression. Whereas previous studies interpreted the circuit activation as a transient, mood-dependent phenomenon, the new evidence suggests that circuit over-activation is likely an underlying vulnerability trait, say the researchers.



Because of its ability to unmask what appears to be a trait marker for major depressive disorder, the researchers suggest that tryptophan depletion may be a useful tool for studying the genetic basis of depression.



"Since brain function appears to be disregulated even when patients are in remission, they need to continue long-term treatment beyond the symptomatic phase of their illness," noted Neumeister, who recently moved to the Yale University psychiatry department.



Also participating in the research were: Drs. Allison Nugent, Tracy Waldeck, Omer Bonne, Earl Bain and Marilla Geraci, David Luckenbaugh, NIMH; Dr. Markus Schwarz, Munich University Hospital of Psychiatry, Dr. Peter Herscovitch, NIH Clinical Center PET Department.



NIMH is part of the National Institutes of Health (NIH), the Federal Government's primary agency for biomedical and behavioral research. NIH is a component of the U.S. Department of Health and Human Services.



Graphic: nimh.nih/press/prtdcircuit.cfm#graphic


CONTACT:

Jules Asher

NIMH press office

301-443-4536

воскресенье, 18 сентября 2011 г.

UNC Study Pinpoints Gene Controlling Number Of Brain Cells

The finding suggests that a single gene, called GSK-3, controls the signals that determine how many neurons actually end up composing the brain. This has important implications for patients with neuropsychiatric illness, as links have recently been drawn between GSK-3 and schizophrenia, depression and bipolar disorder.



In populating the growing brain, neural stem cells must strike a delicate balance between two key processes - proliferation, in which the cells multiply to provide plenty of starting materials - and differentiation, in which those materials evolve into functioning neurons.



If the stem cells proliferate too much, they could grow out of control and produce a tumor. If they proliferate too little, there may not be enough cells to become the billions of neurons of the brain. Researchers at the University of North Carolina at Chapel Hill School of Medicine have now found that this critical balance rests in large part on a single gene, called GSK-3.



The finding suggests that GSK-3 controls the signals that determine how many neurons actually end up composing the brain. It also has important implications for patients with neuropsychiatric illness, as links have recently been drawn between GSK-3 and schizophrenia, depression and bipolar disorder.



One of the genes associated with schizophrenia appears to use GSK-3 as an intermediary to exert its effects on nerve cells. In addition, lithium, a popular treatment for bipolar disorder, acts, in part, by shutting down GSK-3. "I don't believe anyone would have imagined that deleting GSK-3 would have such dramatic effects on neural stem cells," said senior study author William D. Snider, M.D., professor of neurology and cell and molecular physiology, and director of the UNC Neuroscience Center. "People will have to think carefully about whether giving a drug like lithium to children could have negative effects on the underlying structure of the nervous system."



In a study appearing online October 4th in the journal Nature Neuroscience, Snider and his colleagues created a mouse model in which both forms of the GSK-3 gene - designated alpha and beta - had been deleted. They decided to go after GSK-3 - which stands for glycogen synthase kinase 3 - because it is one of the most studied kinases or signaling molecules in all of biology.



The researchers used a "conditional knock-out" strategy to remove GSK-3 at a specific time in the development of the mouse embryo, when a type of cell called a radial progenitor cell had just been formed.



As the brain develops, neural stem cells evolve through three different stages -- neural epithelial cells, radial progenitor cells and intermediate neural precursors. The radial progenitor cells are especially important because they are thought to provide the majority of the neurons of the developing brain but also differentiate themselves to give rise to all the cellular elements of the brain. The researchers discovered that deleting GSK-3 during this second phase of development caused the radial progenitor cells to be locked in a constant state of proliferation.



"It was really quite striking," said Snider. "Without GSK-3, these neural stem cells just keep dividing and dividing and dividing. The entire developing brain fills up with these neural stem cells that never turn into mature neurons."



GSK-3 is known to coordinate signals for proliferation and differentiation within nerve cells through multiple "signaling pathways." Thus, the researchers looked to see what effect deleting the molecule had on some of these pathways. They found that every one of the pathways that they studied went awry.



Snider and his colleagues now want to see if adding GSK-3 back to their genetically engineered mice can convert the proliferating stem cells into neurons, possibly resulting in three to four times as many neurons in the mutants as normal.



"I find that quite interesting because I can't think of any other manipulation that potentially would enable you to simply dial up and down the number of neurons that are generated in the brain," said Snider.



Funding for the studies led at UNC came from the National Institutes of Health. Study co-authors from Snider's laboratory at UNC include lead author Woo-Yang Kim, Ph.D., postdoctoral research associate; Xinshuo Wang, graduate student and Yaohong Wu, chief technician. Researchers from the laboratory of James R. Woodgett, Ph.D. at the University of Toronto also collaborated on the project.


четверг, 15 сентября 2011 г.

Doctors Must Look After Their Health Too - British Medical Journal

Short term counselling followed by a modest cut in work hours may help reduce emotional exhaustion (burnout) and sick leave in doctors, according to a study published on bmj today.


It is well known that doctors have higher rates of depression and suicide than the general population and are less likely to seek help. There have been calls for early intervention programmes to help doctors with mental distress and burnout before their problems interfere with the welfare of patients.


Although such programmes have been shown to reduce stress and exhaustion, it is not clear what type of intervention is best suited to which individual or personal characteristics, or which factors contribute to positive changes.


Dr Karin R?? and colleagues from Norway examined levels of burnout and predictors of reduction in emotional exhaustion after one year, in 227 stressed doctors who participated in voluntary counselling.


Initially, 187 doctors attended a one day individual session, and 40 a one week group based course. Of the 185 doctors who completed follow-up assessments, 70 returned for an additional intervention during the follow-up year, 51 to a one week course and 19 to an individual session.


They completed self report assessments in the four weeks before and the three weeks after the counselling, and a follow-up questionnaire after one year. The data was compared with data obtained from a representative sample of Norwegian doctors in 2003.


One year after a counselling intervention stressed doctors reported a reduction in emotional exhaustion and job stress similar to the level found in a representative sample of Norwegian doctors.


The researchers also found that the number of doctors on full time sick leave had reduced substantially in the year after counselling (35% to 6%), and that the use of psychotherapy also substantially increased from 20% to 53% in the follow-up year.


Interestingly, they found that reduction in work hours after the intervention was also associated with a reduction in emotional exhaustion.


"Our findings indicate that seeking a counselling intervention could be conducive to reduction of burnout among doctors. Considering doctors' reluctance to seek help??¦it is important to offer interventions that facilitate access", conclude the authors.



"Research paper: Counselling for burnout in Norwegian doctors: one year cohort study."

Karin E Isaksson R??, Tore Gude, Reidar Tyssen, Olaf G Aasland

BMJ 2008;337:a2004

Click here to view abstract online


British Medical Journal

понедельник, 12 сентября 2011 г.

The International Neuromodulation Society Reports Record Growth In Professional Membership And Attendance At World Congress

The International Neuromodulation Society (INS) announced that it now represents a professional association of more than 1200 members worldwide, approximately twice as many members as recorded at the close of 2006. With a presence in 33 countries internationally, the INS also welcomed five new national chapters last year: Brazil, Canada, China, France and Korea. The Society's burgeoning growth mirrors the expected growth of the neurotechnology market, which is projected to reach $8.8 billion by 2012.*


Neuromodulation is the alteration -- or modulation -- of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body.


"Our surge in membership reflects not only the tremendous progress that is taking place in the neuromodulation industry, but also an increased appreciation for the International Neuromodulation Society's dedication to its members and representation of the industry worldwide," said Elliot S. Krames, MD, President of the INS and Editor-in-Chief of the journal "Neuromodulation." "The role of the INS is three-fold: to increase awareness and understanding of neuromodulation, to accelerate physician and patient access to therapies and to provide a forum for researchers, physicians, engineers and other key contributors to foster education for this fastest growing segment in medicine today."


Analysts predict a 27 percent annual growth rate in the neuromodulation industry between 2008 and 2012. As regulators approve new treatments for such ailments as psychiatric disorders, epilepsy and traumatic brain injury using deep brain stimulation, the market for this branch of neuromodulation is projected to reach $461 million in 2008 and $1.36 billion by 2012. It is also projected that sales of neuromodulation devices for treatment of obesity-related disorders will reach $479 million by 2012.* Neuromodulation treatments also address conditions such as chronic pain, incontinence, overactive bladder, hearing disorders, Parkinson disease, essential tremor and dystonia. Treatments for blindness, tinnitus and gastrointestinal disorders are currently in development.


"Neuromodulation has now reached a level of commercial and scientific maturity that is producing enormous benefits to patients and profits to investors," said James Cavuoto, Editor and Publisher of Neurotech Reports. "As the epicenter for neuromodulation, the INS is positioned to have a unique and profound role in the continued growth of this industry."


In addition to reporting its highest achievement in membership, the biennial INS World Congress in Acapulco, Mexico last December marked the Society's largest conference to date. Nearly 700 individuals representing 30 countries attended the five-day conference, and more than 260 poster and oral presentations covered the latest developments in neuromodulation. The 2009 World Congress is scheduled to take place in South Korea.


Also in 2007, the INS was named the Most Valuable Nonprofit Society by Neurotech Reports and was awarded the Golden Electrode Award at the 2007 Neurotech Leaders Forum. Additionally, the INS was a recipient of a grant from the National Institute of Neurological Disorders and Stroke (NINDS), a branch of the National Institute of Health (NIH), in support of its scientific meetings.


About The International Neuromodulation Society


The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation -- the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its journal Neuromodulation and chapter websites. For more information, please visit neuromodulation.


* Neurotech Reports. "Neurotech Reports Releases Market Projections through 2012."December 2007.


The International Neuromodulation Society

пятница, 9 сентября 2011 г.

New Data Suggests Doctors Might Not Be Considering Depression Symptoms That Are Important To Patients, Such As Pain And Anxiety

Doctors and depressed patients judge symptom severity and improvement following pharmacotherapy differently, according to data presented at the 20th Annual Meeting of the European College of Neuropsychopharmacology (ECNP) in Vienna, Austria. The data suggest physicians might not be considering symptoms that are important in the eyes of patients, such as pain and anxiety.1


The results are based on a post-hoc analysis of a double-blind, placebo-controlled, multi-center European study in adults with major depressive disorder (MDD) and non-specific pain (n=327). This analysis aimed to compare how patients and physicians estimate overall disease severity at baseline and symptom improvement during short-term treatment of major depression, regardless of treatment group.1 Results showed that physicians treating these patients consider only physician-rated depressive symptoms (as assessed by the Montgomery-Asperg-Depressions Scale or MADRS) when assessing how sick the patient is and whether the patient is getting better. Patients, on the other hand also consider pain and anxiety when judging their own improvement.1


"Previous evidence has suggested that treating both the emotional and the physical symptoms of depression provides patients with the best chance of reaching remission," said Professor Koen Demyttenaere, Department of Psychiatry, University Hospital Gasthuisberg, Leuven, Belgium and lead author of this study. "These qualitative results highlight the need for physicians to also consider a broad spectrum of symptoms including pain and anxiety when treating patients with Major Depressive Disorder and associated pain."


Study results


The two main findings of this new analysis are:


- Disease Severity: At the beginning of the study, physician assessment of the overall disease severity was significantly predicted by depression severity (using the MADRS evaluation tool) and paranoid ideation (as measured by the Symptom Checklist, or SCL-90-R); pain was not a consideration.1 After eight weeks of treatment, physicians' assessment of overall disease severity was significantly predicted by decrease in depression severity (MADRS), being female and of younger age. Among physicians, pain again was not predictive of disease severity.1


- Disease Improvement: Among physicians, overall disease improvement at study end, measured by the Clinical Global Impression of Improvement scale (CGI-I), was significantly positively predicted by decrease in MADRS-rated severity; by decrease in distress in interpersonal sensitivity (measured by the SCL-90-R); and negatively predicted by an older age.1 In contrast, patient rated improvement included improvement in pain. Significant predictors of patient-assessed improvement (as measured by the Patient Global Impression of Improvement scale) were a decrease in pain severity (based on average pain, as measured by the Brief Pain Inventory scale or BPI) depression and anxiety according to SCL-90-R subdomains.1















Furthermore, in this study, the similarity of patient rated disease improvement (PGI-I) and physician rated disease improvement (CGI-I) was investigated by descriptive statistics and a prediction model. In 44.7 percent of cases there was a discrepancy in improvement assessments. In cases of discrepancy, the mean improvement was usually judged higher by physicians than patients (36.3 percent versus 8.4 percent) irrespective of treatment. A lower decrease in MADRS assessed depression severity, pain interference in relation with other people and in interpersonal sensitivity significantly predicted a lower discrepancy between patient and physician improvement. A lower decrease in patient rated pain severity (BPI) and depression (SCL-90-R) significantly predicted a higher discrepancy between physician and patient rated improvement, with the physician rating improvement being higher.


These results provide evidence on the relative importance of different symptoms in depression from a patient perspective and the need to focus beyond core depressive symptoms, when treating depressed patients.


About the Study1


Methodology


Data were derived from a double-blind, placebo-controlled, multi-center study conducted in Belgium, Finland, France, Germany and Slovakia in outpatients ?‰?18 years of age who presented with major depressive disorder (baseline disease severity defined as a Montgomery-Asberg Depression Rating Scale [MADRS] ?‰?20 and Clinical Global Impression-Severity [CGI-S] scale ?‰?4) and moderate pain not attributable to a diagnosed organic pain syndrome (Brief Pain Inventory-Short Form [BPI-SF] average pain score ?‰?3). Physicians were asked to rate severity of depression by using the MADRS, CGI-Severity and Improvement scales. Patients were asked to assess pain using the BPI-SF, psychological symptomatology (including depression) with the symptom checklist 90 items revised (SCL-90-R), and overall improvement after pharmacotherapy with the Patient Global Impression of Improvement (PGI-I). Using a five percent threshold, multivariate regressions were performed as post-hoc analyses to identify predictors of disease assessment at baseline and at the end of the study (LOCF). The study was sponsored by Eli Lilly and Company and Boehringer Ingelheim GmbH.


About Depression


Major Depressive Disorder (MDD) affects approximately 121 million people worldwide.2 The World Health Organization estimates depression will be among the highest-ranking causes of disability in developed countries by 2020, second only to ischemic heart disease worldwide.3 It can happen to anyone of any age, race or ethnicity; however, women are nearly twice as likely to experience depression as men.4 Although it is one of the most frequently seen psychiatric disorders in the primary care setting,5,6 it often goes undiagnosed or is under-treated.2,7 This might be because depressed people often present with physical symptoms rather than emotional complaints; in one large study, 69 percent of patients with MDD reported only physical symptoms as the reason for visiting their physician.8


Complete elimination of symptoms, or remission, is the primary goal of depression treatment. Treating the full spectrum of emotional and physical symptoms to remission significantly decreases a patient's risk of relapse.9


Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.


About Eli Lilly and Company


Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world`s most urgent medical needs.


About Boehringer Ingelheim


The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and


38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.


In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.




References:


1 Demyttenaere KD, et al. Patient-versus Physician-assessed Disease Severity and Outcomes in Patients with Non- specific Pain Associated with Depression


2 World Health Organization. Factsheet - Depression, 2005. Available here. Last visited 26 April 2007


3 Murray CJL, Lopez AD, eds. The Global Burden of Disease; 1996.


4 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision. Washington DC: American Psychiatric Association; 2000:345-428.


5 Ormel J, et al. Common mental disorders and disability across cultures: results from the WHO Collaborative Study on Psychological Problems in General Health Care. JAMA. 1994;272:1741-1748.


6 Spitzer RL, et al. Utility of a new procedure for diagnosing mental disorders in primary care: the PRIME-MD 1000 study. JAMA. 1994;272:1749-1756.


7 Ormel J, Koeter MWJ, van den Brink W, van de Willige G. Recognition, management, and course of anxiety and depression in general practice. Arch Gen Psychiatry. 1991;48:700-706.


8 Simon GE et al. An International Study of the Relation Between Somatic Symptoms and Depression. New Engl J Med. 1999;341(18):1329-35.


9 Paykel ES, et al. Psychol Med. 1995;25(6):1171-1180.

boehringer-ingelheim

вторник, 6 сентября 2011 г.

Total Antidepressant Prescriptions Rise By 16 Million, USA

Prescriptions filled for antidepressant drugs increased from 154 million in 2002 to 170 million in 2005, according to the latest News and Numbers from the Agency for Healthcare Research and Quality.


Among the prescriptions (not including refills) which were written after patients talked with doctors in-person or over the phone. AHRQ data found that in 2005:


-- Psychiatrists - medical doctors who specialize in the treatment of mental disorders - prescribed 29 percent.


-- General practitioners - physicians who provide primary care but are specialty-trained - prescribed 23 percent.


-- Family practitioners - primary care physicians who complete a residency in family medicine -- prescribed 21 percent.


-- Internal medicine specialists - physicians who complete a residency in internal medicine and who focus on the diagnosis and non-surgical treatment of illnesses in adults that are often difficult to diagnose or manage - prescribed 10 percent.


AHRQ, which is part of the U.S. Department of Health and Human Services, works to enhance the quality, safety, efficiency, and effectiveness of health care in the United States. The data in this AHRQ News and Numbers summary are taken from the Medical Expenditure Panel Survey, a detailed source of information on the health services used by Americans, the frequency with which they are used, the cost of those services, and how they are paid. For more information, go to Antidepressants Prescribed by Medical Doctors in Office-Based and Outpatient Settings for the U.S. Civilian Noninstitutionalized Population, 2002 and 2005.


ahrq

суббота, 3 сентября 2011 г.

Royal College Of Nursing Welcomes New Guidance For Providing Acute Mental Health Care For Women, UK

Commenting on today's publication of 'Informed Gender Practice, Mental health Acute Care That Works for Women', by the Care Services Improvement Partnership, Dr. Peter Carter, Chief Executive & General Secretary, of the Royal College of Nursing (RCN), said:


"The RCN welcomes this guidance as it highlights the importance of equality practices in mental health care and should enable women to receive support tailored specifically to their needs.


"We are particularly keen to support this initiative as it is compatible with RCN values and our 8 Principles for Practice which promote effective and meaningful mental healthcare services for women.


"Nurses also acknowledge the vital role they have to play in ensuring that women are able to access services which are safe, provide choice, address experiences of violence and abuse, and promote well-being and recovery approaches.


"This guidance is an effective resource which will be of great use to busy mental health professionals trying to deliver high quality, gender specific care."


The RCN's 8 Principles for Practices was launched in 2005 aiming to promote anti- oppressive practice for all women in any health care setting, thereby promoting good mental health. Copies are available to downloaded at: rcn.uk/__data/assets/word_doc/0005/8843/8_principles_short.doc


Copies of the Informed Gender Practice- Mental Health Acute for Women are available to download at: nimhe.csip.uk/our-work/gender-and-womens-mental-health.html


Royal College of Nursing (RCN) is the voice of nursing across the UK and is the largest professional union of nursing staff in the world. The RCN promotes the interest of nurses and patients on a wide range of issues and helps shape healthcare policy by working closely with the UK Government and other national and international institutions, trade unions, professional bodies and voluntary organisations.


rcn.uk

среда, 31 августа 2011 г.

Even Severe Depression Responds To Changing Thoughts

Moderate to severely depressed clients showed greater improvement in cognitive therapy when therapists emphasized changing how they think rather than how they behave, new research has found.



The results suggest cognitive therapists should concentrate, at least during the first few sessions, on using cognitive techniques to help those with more severe depression to break out of negative thought patterns and to see events in their lives more realistically.



The study found that a concentration on changing behavior - such as having patients schedule activities to get them out of the house, and tracking how they spent their time - did not significantly predict subsequent change in depressive symptoms.



"There has been a lot of attention recently on behavioral approaches to treating severe depression, and that may lead some people to suspect that cognitive techniques are not important for more severely depressed patients," said Daniel Strunk, co-author of the study and assistant professor of psychology at Ohio State University.



"But our results suggest that it was the cognitive strategies that actually helped patients improve the most during the first critical weeks of cognitive-behavioral therapy."



Strunk conducted the study with Melissa Brotman of the National Institute of Mental Health and Robert DeRubeis of the University of Pennsylvania. Their results appear online in the journal Behaviour Research and Therapy and will appear in a later print edition.



The study involved 60 patients who were diagnosed with major depression and who were being treated at two university clinics.



All the patients were being treated by one of six cognitive therapists and agreed to have their therapy sessions videotaped for study.



Two trained raters reviewed the videotapes of the first through the fourth therapy sessions. They rated how much the therapists relied on cognitive and behavioral methods and other aspects of the sessions.



In addition, patients completed a questionnaire at each session that measured their depression levels.



The researchers examined the relationship between specific techniques used by their therapists and the extent of improvement in patients' depression scores from one session to the next.



The study focused on the first few weeks of therapy because other studies suggest that is when patients make the largest improvement in depression levels, Strunk said.



Results showed that patients' depression scores improved significantly when their therapists focused on cognitive techniques, but didn't change when their therapists focused on behavioral techniques.



Other factors were also associated with patient improvement, the study found.



Patients improved more when they collaborated with their therapists about a plan for treatment and followed that plan.



Not surprisingly, patients also showed greater improvement when they were more engaged in the therapy process and were open to suggestions from their therapist.



"If you're a patient and willing to fully commit to the therapy process, our data suggest you will see more benefit," Strunk said.



Strunk said this research is being continued at Ohio State's Depression Treatment and Research Clinic. Researchers there are working with people suffering from depression to understand the nature of cognitive change and how it affects their improvement.



"We're trying to understand if cognitive therapy leads people to a profound change in their basic self view, or if it teaches them a set of skills that they have to continually practice over time," he said.



Strunk said these results suggest that, despite the recent attention given to behavioral approaches to treating depression, cognitive techniques appear to be quite powerful.



"In our sample of cognitive therapy patients, cognitive techniques appeared to promote a lessening of depression symptoms in a way that was not true of behavioral techniques," he said.


воскресенье, 28 августа 2011 г.

Coffee Drinking No Longer So Controversial

Although the American Society for Nutrition's popular "controversy session" at Experimental Biology 2007 focuses on the health effects of coffee drinking, panel chair Dr. James Coughlin, a toxicology/safety consultant at Coughlin & Associates, says that recent advances in epidemiologic and experimental knowledge have transformed many of the negative health myths about coffee drinking into validated health benefits.



Indeed, panel co-chair Dan Steffen, who follows coffee and health issues in the Scientific and Regulatory Affairs group of Kraft Foods, note that the "controversy" is often to educate a wider audience about this transformation in understanding.



Coffee is among the most widely consumed beverages in the world, and Dr. Coughlin says that the preponderance of scientific evidence - some by the panelists - suggests that moderate coffee consumption (3-5 cups per day) may be associated with reduced risk of certain disease conditions, such as Parkinson's disease. Some research in neuropharamacology suggests that one cup of coffee can halve the risk of Parkinson's disease. Other studies have found it reduces the risk of Alzheimer's disease, kidney stones, gallstones, depression and even suicide.



Dr. Coughlin and two distinguished researchers discussed some of the benefits - and a couple of the remaining increased risk factors (possible increase in blood pressure and plasma homocysteine) at the Experimental Biology meeting in Washington, DC.



Dr. Rob van Dam, an epidemiologist at the Harvard School of Public Health and the Harvard Medical School, studies the link between diet and the development of type 2 diabetes. Worldwide, an estimated 171 million persons have diabetes, mostly type 2 diabetes, and an alarming increase to 366 million persons is expected for the year 2030. While increased physical activity and restriction of energy intake can substantially reduce risk of type 2 diabetes, he believes insight into the role of other lifestyle factors may contribute to additional prevention strategies for type 2 diabetes.



In recent epidemiological studies in the U.S., Europe and Japan, persons who were heavy coffee consumers had a lower risk of type 2 diabetes than persons who consumed little coffee. Interestingly, he says, associations were similar for caffeinated and decaffeinated coffee, suggesting that coffee components other than caffeine may be beneficial for glucose metabolism.
















Coffee contains hundreds of components including substantial amounts of chlorogenic acid, caffeine, magnesium, potassium, vitamin B3, trigonelline, and lignans. Limited evidence suggests that coffee may improve glucose metabolism by reducing the rate of intestinal glucose absorption and by stimulating the secretion of the gut hormone glucagon-like peptide-1 (GLP-1) that is beneficial for the secretion of insulin. However, most mechanistic research on coffee and glucose metabolism has been done in animals and in lab tubes and therefore metabolic studies in humans are currently being conducted. Further research may lead to the development or selection of coffee types with improved health effects.



Dr. Lenore Arab, a nutritional epidemiologist in the David Geffen School of Medicine at UCLA, notes that the first coffee controversy dates back 430 years when in 1570 some monks petitioned the pope to condemn this drink, so popular among Muslims. Pope Clement VIII, liking how it kept the monks from falling sleep during mass, purportedly blessed it instead. The rest, including the United States' wholesale conversion to coffee following the Boston Tea Party, is history.



In reviewing the latest epidemiologic literature on cancers and coffee, Dr. Arab has found there to be close to 400 studies of the associations between coffee consumption and cancers various at various sites. The earlier controversy with regard to colon cancer was based on flawed analyses, she says. More thorough analyses and the accumulation of evidence suggest no negative effect on the incidence of colon cancer, and possible protective effects for adenomas of the colon as well as for rectal cancer and liver cancer. Mechanisms which might contribute to a possible anticarcinogenic effect include reduction in cholesterol, bile acid and neutral sterol secretion in the colon, increased colonic motility and reduced exposure of epithelium to carcinogens, the ability of diterpenes to reduce genotoxicity of carcinogens, and lower DNA adduct formation, and the ability of caffeic acid and chlorogenic acid to decreased DNA methylation. In other cancers - breast, ovarian, and prostate - the evidence is not suggestive of either risk or protection. There are two areas, says Dr. Arab, in which there is some evidence of increased risk: leukemia and stomach cancer. The evidence for the former is intriguing, for the latter insubstantial. She concludes that a systematic review of the newer data for liver, rectal, stomach cancer and for childhood leukemia is due.





Contact: Sylvia Wrobel


Federation of American Societies for Experimental Biology

четверг, 25 августа 2011 г.

CAMH Scientist First Psychiatrist To Win Royal College Medal Award In Medicine

Dr. Jeffrey Meyer, and Head of Neurochemical Imaging in the Mood Disorders at the Centre for Addiction and Mental Health (CAMH), is the first psychiatrist to be honoured with the Royal College Medal Award in Medicine in the award's 60 year history.



For over 30 years, scientists believed that monoamines - mood-related chemicals such as serotonin, norepinephrine and dopamine - are low in the brain during episodes of major depression. This is commonly referred to as a "chemical imbalance", but no one had ever found a convincing explanation for monoamine loss. In 2006, Dr. Meyer unlocked this mystery and released a study that provided an explanation of how the "chemical imbalance" occurs in major depressive episodes - the new leading monoamine theory of depression.



Dr. Meyer, who also holds a Canada Research Chair in Neurochemistry of Depression, investigated whether brain monoamine oxidase A (MAO-A) - an enzyme that breaks down chemicals like serotonin, norepinephrine and dopamine - was higher in those with untreated depression. The results showed that in major depression MAO-A was significantly higher in every brain region that the scientists investigated. On average, MAO-A was 34 per cent higher.



"It's a wonderful honour for Dr. Meyer, for CAMH, and for psychiatry that a clinical scientist's work is being recognized in this way," said Vice President of Research Dr. Bruce G. Pollock. "The Royal College winners have been amongst Canada's most outstanding emerging investigators in medicine and surgery for the past 60 years, and we're proud to have Dr. Meyer included in this distinguished group."


Notes:


The Royal College of Physicians and Surgeons of Canada (RCPSC) is a national, nonprofit organization established in 1929 by a special Act of Parliament to oversee the medical education of specialists in Canada. Each year the RCPSC awards the Medal Award in Medicine to recognize original work in clinical investigation and basic science.



The Centre for Addiction and Mental Health (CAMH) is Canada's largest mental health and addiction teaching hospital, as well as one of the world's leading research centres in the area of addiction and mental health. CAMH combines clinical care, research, education, policy development and health promotion to help transform the lives of people affected by mental health and addiction issues. CAMH is fully affiliated with the University of Toronto, and is a Pan American Health Organization/World Health Organization Collaborating Centre.


понедельник, 22 августа 2011 г.

Postpartum Depression Is Top Priority For New ACOG President

Today Gerald F. Joseph Jr, MD, of Louisiana, became the 60th president of The American College of Obstetricians and Gynecologists (ACOG), based in Washington, DC. During his inaugural speech at ACOG's Annual Clinical Meeting, Dr. Joseph announced that postpartum depression is the theme of his presidential initiative.


"While in an ideal world, the newly delivered mother is at the peak of her reproductive health, with a beautiful child and, ideally, a supportive, loving family, this unfortunately is not always the case," said Dr. Joseph. "Studies show that this is a most vulnerable time for our patients, especially those prone to depression or those with a history of depression." Complicating matters is that the new mother often can't bring herself to admit to any problems or negative emotions due to societal pressures, he said. Instead of asking for help, she may feel guilty for not being 'grateful' or a 'good' mother.


Dr. Joseph explained that the 'baby blues,' which affect as many as 80% of new mothers, usually start early after delivery and spontaneously resolve within a very short period of time. "But what happens when these negative feelings don't resolve and true major depression becomes a part of the process?" he asked. "This can be devastating for the mother, the child, the partner, the family, and the ob-gyn who is caring for her."


There are three areas in particular that need to be addressed, according to Dr. Joseph. "First, we need to determine the true prevalence and incidence of postpartum depression," he said. Because definitions of depression vary among different studies, postpartum depression is estimated to range anywhere from five percent to more than 25 percent, depending on these changing definitions and the diversity of populations studied. "Second, the available screening tools to assess potentially at-risk pregnant women often are imprecise and leave much to be desired. And, finally, we need to develop evidence-based guidelines for ACOG members to screen for postpartum depression."



"We also need to know how ACOG Fellows screen and identify patients suffering from postpartum depression," Dr. Joseph continued. "When do they counsel? How do they treat? Do they refer to other specialists for treatment? What kind of local programs are available for education and support? These are all questions that we need answers to."


In addition, Dr. Joseph said, "Let us hope that this is the year for real, meaningful health care reform. Effective, affordable health care needs to start on the front end with prevention of disease, rather than the acute care on the back end that too many of our citizens receive today. We end up caring for sicker patients and paying much more for expensive acute care rather than the less expensive preventive care. As president, I assure you that ACOG will continue to push for preventive care for all."















Dr. Joseph is a senior consultant in gynecology at the Ochsner Health Center in Covington, LA, and clinical assistant professor of obstetrics and gynecology at Louisiana State University and Tulane University in New Orleans. He has been an ACOG Fellow since 1978. Dr. Joseph has chaired the Committee on Scientific Program and the task forces on Enhancing Practice Satisfaction and District and Section Contributions. He has been a member of ACOG's Executive Board and has served as the Executive Board liaison to the Society for Maternal-Fetal Medicine. Dr. Joseph has served on the committees on Gynecologic Practice, Nominations, Credentials, and Long-Range Planning and on the task forces on Medical Student Recruitment, Nominations Process, and Scope of Practice. He has been a member of the Council of District Chairs, the Grievance Committee's Appeals Panel Committee, and the medical advisory board for pause® magazine.


Dr. Joseph has served in numerous regional leadership positions, including chair of ACOG District VII and the Louisiana Section. He has also served as District VII scientific program chair and as a member of the Missouri Section Advisory Council. Dr. Joseph is past president of the New Orleans Gynecological and Obstetrical Society and the Southeastern Obstetrical and Gynecological Society. He has been active in the Central Association of Obstetricians and Gynecologists for many years, serving as a member of the board of trustees and as vice president.


Dr. Joseph received his medical degree from Tulane University and completed his residency at Louisiana State University in Shreveport.


The American College of Obstetricians and Gynecologists (ACOG) is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization, ACOG: strongly advocates for quality health care for women; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing women's health care.


Source
American College of Obstetricians and Gynecologists

пятница, 19 августа 2011 г.

Link Between Depression And Cardiovascular Disease

Depression has long had a popular link to cardiovascular disease and death. However, only during the last 15 years scientific evidence supporting this common wisdom has been available (Glassman et al., 2007a). Since the early 1990s studies have reported prevalences of major depression between 17% and 27% in hospitalized patients with coronary artery disease (CAD) (Rudisch & Nemeroff, 2003).



It is becoming clear that the comorbidity of depression and cardiovascular disease does not occur by chance but the mechanisms responsible for this relationship is poorly understood. Platelet abnormalities, autonomic tone, and health behaviors have all been implicated. There exists also the possibility that depression and vascular disease share certain vulnerability genes (McCaffery et al., 2006).



Moreover, it is now apparent that depression aggravates the course of multiple cardiovascular conditions (Glassman et al., 2007) and has regularly been shown to lower adherence to prescribed medication and secondary prevention measures (Glassman et al., 2007b).



Few randomized controlled trials have evaluated the efficacy of treatments for major depression in patients with coronary artery disease.



Depression and cardiovascular disease



* Depression observed following acute coronary syndrome (ACS) is common and associated with an increased risk of mortality. Medically healthy individuals who suffer from depression are at significantly increased risk of developing heart attacks and strokes later in life (Glassman et al., 2007).



* Acute coronary syndrome is both psychologically and physiologically stressful, and it is common to attribute depression observed following ACS to that stress (Glassman et al., 2006)



Furthermore, the Heart rate variability (HRV), a well-recognized measure reflecting fluctuations in autonomic activity, is an independent predictor of death. Earlier studies show that, after myocardial infarction, HRV values increase approximately 50% between 3- and 12-weeks. In post-ACS patients with depression, improvement in HRV could therefore result from the pharmacological action of an antidepressant drug, from an improving mood independent of the drug, or as a result of recovery from the acute cardiac injury.



Depression treatment among patients with coronary artery disease



Few adequately controlled trials evaluated whether antidepressant treatments are either safe or effective in patients with coronary artery disease (CAD). The largest of these, the Sertraline Antidepressant Heart Attack Trial (SADHART) (Glassman et al., 2002) was designed to evaluate the safety and efficacy of sertraline hydrochloride for treatment of MDD in ACS. No adverse cardiovascular effects of sertraline treatment were detected, sertraline was both safe and effective in post-MI depression and observed a reduction in death and recurrent myocardial infarction. Planned subgroup analyses showed a clear benefit of sertraline over placebo for patients with recurrent depression and those with more severe depression.
















In addition, the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy, a randomized, controlled, 12-week, parallel-group trial (CREATE) (Lesperance et al., 2007), was the first trial specifically designed to evaluate the short-term efficacy and tolerability of 2 depression treatments in patients with CAD: citalopram, a first-line SSRI antidepressant and interpersonal psychotherapy (IPT), a short-term, manual-based psychotherapy focusing on the social context of depression. The trial documents the efficacy of citalopram administered in conjunction with weekly clinical management for major depression among patients with coronary artery disease and found no evidence of added value of IPT over clinical management. Similar to the results of SADHART CREATE found the benefits of SSRIs for patients with CAD to be clearer for recurrent episodes of major depression than for first episodes.



Clinical implications



* Depression is a painful state, and it should be treated aggressively when indicators of benefit are present; major depression following myocardial infarction is consistently associated with about a 3-fold increase in cardiac mortality and evidence continues to accumulate (Glassman et al., 2007b).



* Major depression severely impairs heart rate variability recovery following an acute coronary event. It is now clear, that depression is also associated with biological changes involving increased heart rate, inflammatory response, plasma norepinephrine, platelet reactivity, absent post-ACS HRV recovery -- all of which is associated with life-threatening consequences. It also impairs compliance with doctors advice and health behaviors.



* Based on study results and those of previous trials, the selective serotonin-reuptake-inhibitors (SSRI) citalopram or sertraline plus clinical management should be considered as a first-step treatment for patients with CAD and major depression albeit there is still a clear need for additional studies evaluating interventions to prevent the cardiac prognostic impact of depression.



* From a clinician's point of view, patients with depression after myocardial infarction, especially those with prior episodes, should be both carefully watched and aggressively treated, because they are at an elevated cardiac risk and less likely to get better spontaneousely.







References



Glassman AH. Depression and cardiovascular comorbidity. Dialogues Clin Neurosci 2007a;9(1):9-17



Glassman AH, Bigger JT, Gaffney M. Heart Rate Variability in Acute Coronary Syndrome Patients with Major Depression, influence of Sertraline and Mood Improvement. Arch Gen Psychiatry 2007b;64:9



Glassman AH, Bigger JT, Gaffney M, et al. Onset of major depression associated with acute coronary syndromes: relationship of onset, major depressive disorder history, and episode severity to sertraline benefit. Arch Gen Psychiatry 2006;63(3):283-8



Glassman AH, O'Connor CM, Califf RM, et al.; Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA 2002;288(6):701-9



Lesperance F, Frasure-Smith N, Koszycki D, et al.; CREATE Investigators. Effects of citalopram and interpersonal psychotherapy on depression in patients with coronary artery disease: the Canadian Cardiac Randomized Evaluation of Antidepressant and Psychotherapy Efficacy (CREATE) trial. JAMA 2007;297(4):367-79



McCaffery JM, Frasure-Smith N, Dube MP, et al. Common genetic vulnerability to depressive symptoms and coronary artery disease: a review and development of candidate genes related to inflammation and serotonin. Psychosom Med 2006;68(2):187-200



Rudisch B, Nemeroff CB. Epidemiology of comorbid coronary artery disease and depressi on. Biol Psychiatry 2003;54:227-240.