FDA Approves Viibryd to Treat Major Depressive Disorder

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Viibryd tablets (vilazodone hydrochloride) to treat major depressive disorder in adults.

Major depressive disorder, also called major depression, is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of major depression often recur throughout a person's lifetime, although some may experience only a single occurrence.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide. All people with major depression do not experience the same symptoms.

"Major depressive disorder is disabling and prevents a person from functioning normally," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. "Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression."

The most frequent adverse reactions reported by patients taking Viibryd in clinical trials included diarrhea, nausea, vomiting, and insomnia.

The drug will be available in 10, 20 and 40 milligram tablets.

Viibryd and all other antidepressant drugs have a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show this increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior. The warning says depression and other serious psychiatric disorders themselves are the most important causes of suicide and that close monitoring of patients starting these medications is necessary.

Viibryd is manufactured by PGxHealth, New Haven, Conn.

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Home-Based Mindfulness Treatment Curbs Depression in Adults With Epilepsy

A telephone- and Internet-delivered mindfulness-based depression treatment has been shown to significantly reduce depressive symptoms in adults with epilepsy, according to a study by Emory University public health researchers, published in the November 2010 issue of Epilepsy & Behavior.

The treatment called UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based depression prevention and treatment program. Based on mindfulness-based cognitive therapy, the weekly program was designed for group delivery via the phone or Web. It involves eight, hour-long sessions focused on increasing knowledge about depression, epilepsy, cognitive-behavioral therapy (CBT) and mindfulness.

Forty participants were randomly assigned to participate in the intervention or waitlist groups. Depressive symptoms and other outcomes were measured at baseline, after eight weeks, and after 16 weeks.

Depressive symptoms decreased by 64 percent in the intervention group but only by 15 percent in the waitlist group. There was no significant difference in results between participants who received the intervention via telephone or Internet.

“The Project UPLIFT intervention was effective in teaching people with epilepsy the knowledge and skills associated with reducing their symptoms of depression,” says lead study author Nancy Thompson, PhD, associate professor of behavioral science and health education at Emory’s Rollins School of Public Health. “Addressing the mental health needs of this population is important as many people with epilepsy – between 32 percent and 48 percent – report being depressed as well as feeling isolated and stigmatized.”

Future studies of the UPLIFT program will target other populations at risk of depression, such as caregivers or persons with disabilities, who may benefit from a home-based treatment. The U.S. Centers for Disease Control and Prevention funded the Project UPLIFT pilot study.

In addition to Thompson, study authors were Elizabeth Reisinger Walker, Natasha Obolensky, Ashley Winning, Christina Barmon, and Colleen Dilorio, of the Rollins School of Public Health; and Michael Compton of the Emory School of Medicine.


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FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

Venlafaxine hydrochloride extended-release capsules in 37.5 milligram, 75 milligram and 150 milligram strengths have been approved to be manufactured by TEVA Pharmaceuticals, North Wales, Pa.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

Symptoms of depression can include feelings of sadness, anxiety, emptiness, hopelessness, guilt, worthlessness or helplessness. Irritability and restlessness are also common symptoms of depression. Many people with depression lose interest in activities or hobbies and feel tired all the time.

The prescribing information (label) for the generic drug may differ from that of Effexor XR capsules because some uses of the drug and parts of the label are protected by patents and/or exclusivity held by the Effexor manufacturer, Wyeth Pharmaceuticals Inc.

Generic venlafaxine hydrochloride will have the same safety warnings as Effexor XR.

The drug has a boxed warning indicating that antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. The warning also notes that depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

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Heart Association Call for Routine Screening of Heart Patients for Depresssion is Premature, Johns Hopkins Expert Says

A Johns Hopkins cardiologist well known for his studies on the links between depression and heart attack says there is not nearly enough evidence yet to support a recent call by the American Heart Association (AHA) to begin routine screening of millions of Americans for depression.

Roy Ziegelstein, M.D., says the September 2008 recommendation is "premature," and "a massive undertaking" that would consume a vast amount of clinic staff time and effort to analyze and follow-up on the questionnaires involved in screening, without a demonstrated benefit in improving patient care.

An estimated 80 million Americans have some form of heart disease.

Reporting on a collection of more than 1,500 clinical studies from around the world, from which 17 were selected for detailed review, Ziegelstein and his colleagues point to the absence of any scientific proof that depressed heart patients live longer or fare better over the long term if they are screened for depression and treated with drugs and other therapy.

The team's report, believed to be the largest, most comprehensive review of all research in the field, is set to appear in the Nov. 12 edition of the Journal of the American Medical Association. Its publication is timed to coincide with the AHA's annual Scientific Sessions in New Orleans.

"Our analysis showed that depression screening tools worked reasonably well in identifying who is depressed and who is not, based on such symptoms as feeling blue or suddenly withdrawing from routine activities," says Ziegelstein, a professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute.

Yet he points out that that about one in five people with depression would not be picked up by screening and fewer than half of those identified as depressed by the screening process will actually be depressed when evaluated more thoroughly.

The team also found that treating depression in people with heart disease only accounted for a 1 percent to 4 percent change in symptoms compared to those treated with placebo. Ziegelstein says this is "too low to expect meaningful benefits for many people, particularly since screening methods are not very precise in identifying people who would benefit from the treatment."

In addition, he says, before routine screening, physicians need to consider the potential for harm to people, as no studies have fully analyzed any negative impact from treatment side effects, or misdiagnosis and labeling of heart patients as depressed.

"Understandably, then, we cannot in good conscience support screening all heart patients," says Ziegelstein, vice chairman of medicine at Johns Hopkins Bayview Medical Center.

"This is a difficult call for us to make, but it is in the best interests of patients at this time," he adds.

The AHA estimates that one in four heart attack patients experiences feelings of sadness and develops a gloomy outlook as a result of the injury. Such depression more than doubles the risk of death, according to some studies.

But rather than massive, costly screening at this point, Ziegelstein says physicians need to "get to know their patients better, as real people," and to make clinical assessments of each patient's mood for signs of depression as they talk to them about other things related to their health, including exercise routines, dietary habits, and use of medications.

"Physicians can start by listening more to their patients during examinations and by not interrupting them, which research shows often happens within the first 20 seconds after patients initiate conversation," he says.

Making a diagnosis of depression is not difficult, he adds, "if they use their examination time well and ask the right questions," not focusing only on the physical issues but also on the patient's overall state of well-being and daily routine.

"Look and listen for signs of low mood or sadness, or find out if a patient has recently stopped or cut back on social contacts or things they used to do for fun," says Ziegelstein.

As part of the research review, an international team of researchers sorted over 1,500 clinical studies of depression to identify studies that looked at screening heart patients for depression, treating and monitoring them. From these, the team, led by Johns Hopkins-trained psychologist Brett Thombs, Ph.D., now an assistant professor at McGill University in Montreal, grouped together the data from 11 studies that used proven depression screening tests.

Selected screening studies covered more than 4,000 men and women, and most involved one of four commonly used questionnaires to diagnose depression. Results showed that these tests were on average 80 percent accurate in detecting people who were actually depressed.

Another half-dozen clinical trials were evaluated for the immediate health effects of drug treatment and counseling among nearly 3,000 men and women who had been screened and found to be depressed. Drug treatment mostly involved prescribing mood-raising selective serotonin reuptake inhibitors.

Researchers could not find a single study that screened heart patients for depression and then demonstrated lasting improvements to health or even a longer lifespan.

"We don't have any evidence that screening for depression will benefit people with heart disease. What we really need is more research on how best to help them adopt healthy behaviors that combat depression, such as how to stop smoking, exercise regularly and maintain a healthy weight," says Thombs.

Ziegelstein says the team's collective research will contribute to a better understanding of how depression influences heart disease. He also says it will increase physician support to broaden clinical care of depressed heart patients to include increased input from psychologists, psychiatrists and internists, as part of what he calls a more "collaborative care model" that encompasses as much care of the mind and overall body as it does the physical heart.

Funding support for Ziegelstein's research was provided by the National Center for Complementary & Alternative Medicine, a member of the National Institutes of Health, and by the Miller Family Scholar Program.

In addition to Ziegelstein and Thombs, other researchers who contributed to this study were Cheri Smith, M.L.S., and Karl Soderlund, B.S., at Johns Hopkins. International co-investigators were Peter de Jonge, Ph.D., at the University Medical Center Groningen, Netherlands; James Coyne, Ph.D., at the University of Pennsylvania School of Medicine, in Philadelphia; Mary Whooley, M.D., at the University of California, San Francisco; Nancy Frasure-Smith, Ph.D., also at McGill; Alex Mitchell, M.Sc., M.R.C. Psych, at the Leicester Royal Infirmary, United Kingdom; Marij Zuidersma, M.Sc., also at Groningen; Chete Eze-Nliam, M.D., M.P.H., at Interfaith Medical Center in Brooklyn, N.Y.; and Bruno Lima, at Federal University of Ceara School of Medicine, in Fontalez-ce, Brazil.

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Cognitive Behavioral Therapy Effective for Treating Trauma Symptoms in Children and Teens

Individual and group cognitive behavioral therapy is effective in reducing depressive disorders, anxiety, post traumatic stress disorder or other trauma symptoms in children and teenagers, according to an extensive review of dozens of studies conducted by the Task Force on Community Preventive Services, an independent group of scientists partially funded by the federal government.

However, many clinicians are using other types of therapy, such as art, play or drug therapy, which are not proven to be effective. The findings are published in the September issue of the American Journal of Preventive Medicine.

Cognitive therapy focuses on a person′s thoughts and beliefs, and how they influence mood and actions, and aims to change a person′s distorted thinking patterns. Behavioral therapy focuses on actions and aims to change unhealthy behavior patterns.

Mental Health organizations have estimated that more than 75 percent of U.S. mental health professionals who treat children and teens with post traumatic stress disorder are using therapies that are not known to be effective.

“The good news is there is substantial research showing the effectiveness of group or individual cognitive behavioral therapy in treating children and teens experiencing the psychological effects of trauma. We hope these findings will encourage clinicians to use the therapies that are shown to be effective,” said Robert Hahn, Ph.D., MPH, coordinating scientist at the Centers for Disease Control and Prevention’s Community Guide Branch and an author of the Task Force report.

In addition to individual and group cognitive therapy, the Task Force evaluated other interventions including art therapy, play therapy, drug therapy, and psychological debriefing, but could not find sufficient scientific evidence to support their use. The Task Force recommends that more research be done on other forms of therapy to determine whether or not they might be effective.

“Childhood trauma is a widespread problem with both short- and long-term consequences. Many kids with symptoms of trauma go undiagnosed, which can lead to unhealthy behaviors in adulthood such as smoking and alcohol or drug abuse,” Hahn said. “Increased screening to identify trauma symptoms in children can help these kids get the therapy they need and lessen the likelihood they will engage in these risky health behaviors when they become adults.”


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Depression and Diabetes: Fellow Travelers, Researchers Say

Researchers have long known that type-2 diabetes and depression often
go hand in hand. However, it's been unclear which condition develops
first in patients who end up with both. Now, a new study led by Johns
Hopkins doctors suggests that this chicken-and-egg problem has a dual
answer: Patients with depression have an increased risk of developing
type-2 diabetes, and patients with type-2 diabetes have an increased
risk of developing depression.

For the study, published in the June 18 Journal of the American
Medical Association, diabetes expert Sherita Hill Golden, M.D.,
M.H.S., and her colleagues took advantage of data generated by the
Multi-Ethnic Study of Atherosclerosis (MESA), which examined risk
factors for atherosclerosis, or hardening of the arteries, in an
ethnically diverse group of 6,814 men and women between ages 45 to
84. Participants in the MESA study identified themselves when they
enrolled as white, black, Hispanic or Chinese.

During MESA, participants made three visits to clinics over the
course of three years to be examined for various atherosclerosis risk
factors, including type-2 diabetes and symptoms of depression, which
could serve as a precursor for full-blown clinical depression.

The study also collected information on other atherosclerosis risk
factors, such as participants' body-mass indices, blood pressure,
diet and exercise patterns, and smoking habits, as well as
information correlated with health in general, such as income and
socioeconomic factors.

Mining the data for their own purposes, Golden and her colleagues
excluded from their analysis all participants who had high fasting
glucose, an indication of diabetes, at the initial clinic visit. They
then looked to see whether participants who initially had elevated
symptoms of depression, as indicated through a questionnaire, were
more likely than those who didn't to develop high fasting glucose at
the end of the three-year study period.

Results showed that those with elevated depressive symptoms were 42
percent more likely overall to develop diabetes by the end of the
study than those without these symptoms. Moreover, the stronger the
symptoms, the higher the risk of diabetes, a "dose response" that
lends strength to the findings.

Even when the researchers accounted for such factors as overweight,
lack of exercise, and smoking, the risk of developing diabetes was
still 34 percent higher for patients with depressive symptoms.

To investigate whether diabetes could lead to depression, Golden and
her colleagues used the same pool of MESA information and excluded
those who had elevated depressive symptoms at the initial clinic
visit. Then, they looked to see whether those who had high fasting
glucose-with or without a formal diagnosis of diabetes-were more
likely to develop depressive symptoms by the end of the study.

The researchers found that patients treated for diabetes, about 9
percent of the group, were about 54 percent more likely to develop
elevated depressive symptoms than those without diabetes.

Surprisingly, those with prediabetes or untreated diabetes were about
25 percent less likely to develop elevated depressive symptoms than
people with normal fasting glucose, a finding Golden's team cannot
explain at this time.

Golden, an associate professor of medicine and epidemiology at the
Johns Hopkins University School of Medicine, speculates that
depression may lead patients to develop behaviors that trigger
diabetes or make it worse, such as overeating, not exercising or
smoking. Similarly, keeping up with the often extensive treatment
regimens to care for their diabetes may make patients' depression
worse. Understanding how one condition might lead to another could
improve treatments for both problems, she says.

"Having both diabetes and depression can make it difficult for
patients to get the good clinical outcomes that we like to see for
each of these conditions," says Golden. "To make sure that patients
with diabetes and depression receive the best care, we wanted to get
to the bottom of the connection between these two conditions.

"It's important that doctors be attuned to look for both conditions
in patients at risk for either diabetes or depression," Golden adds.
"We may want to develop interventions for both treatments, instead of
just one or the other."

Other Johns Hopkins researchers who participated in this study
include Mariana Lazo, M.D.. M.Sc.; Hochang Benjamin Lee, M.D.; and
Constantine Lyketsos, M.D., M.H.S.

The MESA study was supported by grants from the National Heart, Lung,
and Blood Institute. Golden and her colleagues' research was
supported by a Patient-Oriented Mentored Scientist Award through the
National Institute of Diabetes and Digestive and Kidney Diseases.

Mayo Clinic Study Reveals Rural, Unmarried Women at Higher Risk for Depression

mdash; Mayo Clinic research suggests unmarried women living in rural areas have lower self-rated health status than their married counterparts. This lower health status often includes greater instances of self-assessed feelings of depression. The results of the study were recently published in the Journal of Evaluation in Clinical Practice. They suggest that primary care physicians should take a proactive role in addressing health concerns of single women.

"We tend to focus on disease, but as the World Health Organization notes, good health includes physical, mental and social well-being and not merely the absence of disease," says James Rohrer, Ph.D., of Mayo Clinic's Department of Family Medicine and lead author of the study. "Being single may be associated with a greater degree of separation from usual health care, as many women gain insurance through a spouse or a former spouse. Lack of social support also may contribute to poor health among some single women."

Researchers used a cross-functional survey to gather self-ratings of overall health among female primary care patients aged 18 years and older who live in cities with a census of approximately 3,000. The study analyzed marital status and self-assessed mental health as potential risk factors for poor overall self-rated health among female primary care patients. The analysis revealed that single or divorced women are more prone to poor self-rated health compared to married women. Women who described themselves as being depressed also had worse overall health. Women aged 65 and older had an even higher risk of poor self-
rated health.

While the data were finalized in 2000, Dr. Rohrer notes that current economic concerns may exacerbate the risk.

"Economic problems increase feelings of emotional stress. People today are worried about, among other things, the mortgage crisis and high gas prices. Many are left wondering how they are going to pay for necessities. Statistically, rural, unmarried women are more often economically depressed than their married counterparts," says Dr. Rohrer. "If the economy worsens, we will see a significant impact on visits to primary care physicians and nurses. Medical providers are trained to focus on the biological and psychological. But economic causes of poor health? I don't think that receives a lot of air time in medical school."

Patients experiencing feelings of poor self-rated mental health can address these concerns with screening, health promotion and treatment programs. Screening can be followed-up with self-help materials, support groups and medication if deemed appropriate by the physician. Referrals to financial counseling might have indirect therapeutic value.

Other study authors are Matthew Bernard, M.D., Department of Family Medicine; Norman Rasmussen, psychologist, Departments of Family Medicine and Psychiatry and Psychology; Halina Woroncow, M.D., Kasson Clinic, Department of Family Medicine, all of Mayo Clinic Rochester; and Yan Zhang, Ph.D., Department of Family Medicine, Texas Tech University Health Sciences Center.