A study by Jay Fournier and Rob DeRubeis shows antidepressants work best for severe depression, but provide little to no benefit otherwise.
Link to the article on Penn's home page: http://www.upenn.edu/pennnews/article.php?id=1791
Link to NY Times article: http://www.nytimes.com/2010/01/06/health/views/06depress.html
Excerpt from Penn's home page:
Penn Study Shows Antidepressants Work Best for Severe Depression, Provide Little to No Benefit Otherwise
January 05, 2010
PHILADELPHIA –- A study of 30 years of antidepressant-drug treatment data published today in the Journal of the American Medical Association shows that the benefit of antidepressant medication compared with placebo may be minimal or nonexistent in patients with mild or moderate symptoms. University of Pennsylvania researchers say, however, the benefit of medications is substantial for patients with very severe depression.
Ultimately, according to the study, the majority of patients who were prescribed antidepressants did not suffer from a severity of depression that would be improved by the medications.
The research team, led by psychologists at Penn, analyzed data from studies that spanned a 30-year period to gauge the benefit of antidepressant medication compared to placebo pills across a range of patients with varying degrees of depression. The team collected data from placebo-controlled trials of antidepressants approved by the U.S. Food and Drug Administration for the treatment of Major or Minor Depressive Disorder. Studies comprised adult outpatients and included a medication vs. placebo comparison for at least six weeks. Researchers calculated depression severity scores before and after treatment using the standard Hamilton Rating Scale for Depression.
The scientists learned that medication vs. placebo differences varied substantially, relative to the severity of depression suffered by patients. Those patients shown to have less severe depression experienced little to no greater improvement in their symptoms from antidepressant medication as compared to a placebo sugar pill.
The results imply that doctors who are advising treatment for patients with mild or moderate cases of depression should consider the lack of evidence for specific benefits of the medications and compare the expected costs and benefits of the medications against alternatives such as self-help, exercise or psychological therapy.
“Antidepressant medications represent the best established treatment for Major Depressive Disorder, but there is little evidence that they have a specific pharmacological effect relative to pill-placebo for patients with less severe depression,” said Robert DeRubeis, principal investigator and professor in the Department of Psychology in Penn’s School of Arts and Sciences.
Researchers concluded that the ability of antidepressant medications to reduce depressive symptoms varied considerably. For people whose depression was considered to be mild, moderate or even severe, little evidence showed that the medications yield specific benefit beyond what is provided by engagement in treatment and the resulting boost in the patient’s expectation for improvement.
“For very severe depressions, the benefits of medications are clear and substantial,” said Jay Fournier, lead author and a doctoral candidate in Penn’s Department of Psychology. “But for others, the results of this study demonstrate how important it is for persons who are suffering from depression to take an active role in their care, regardless of the severity of their symptoms. Even placebo treatments help most people, and, although we do not fully understand how placebos work, part of the benefit comes from patients taking their depressive symptoms seriously and acting on their concern about their own mental health.”
The study was supported by the National Institute of Mental Health.
Research was conducted by DeRubeis of Penn, Fournier of Penn and Pittsburgh’s Western Psychiatric Institute and Clinic, Jay Amsterdam of the Department of Psychiatry in Penn’s School of Medicine, Steven Hollon and Richard Shelton of Vanderbilt University, Sona Dimidjian of the University of Colorado at Boulder and Jan Fawcett of the University of New Mexico.
Excerpt from NY Times Article:
Popular Drugs May Help Only Severe Depression
By BENEDICT CAREY
Published: January 5, 2010
Some widely prescribed drugs for depression provide relief in extreme cases but are no more effective than placebo pills for most patients, according to a new analysis released Tuesday.
JB Reed/Bloomberg News
The latest study may settle a debate about drugs like Prozac.
The findings could help settle a longstanding debate about antidepressants. While the study does not imply that the drugs are worthless for anyone with moderate to serious depression — many such people do seem to benefit — it does provide one likely explanation for the sharp disagreement among experts about the drugs’ overall effectiveness.
Taken together, previous studies have painted a confusing picture. On one hand, industry-supported trials have generally found that the drugs sharply reduce symptoms. On the other, many studies that were not initially published, or were buried, showed no significant benefits compared with placebos.
The new report, appearing in The Journal of the American Medical Association, reviews data from previous trials on two types of drugs and finds that their effectiveness varies according to the severity of the depression being treated.
Previous analyses had found a similar pattern. But the new study is the first to analyze responses from hundreds of people being treated for more moderate symptoms, as are most people who seek care.
“I think the study could dampen enthusiasm for antidepressant medications a bit, and that may be a good thing,” said Dr. Erick H. Turner, a psychiatrist at Oregon Health and Science University. “People’s expectations for the drugs won’t be so high, and doctors won’t be surprised if they’re not curing every patient they see with medications.”
But Dr. Turner added, “The findings shouldn’t dampen expectations so much that people refuse to even try medication.”
A team of researchers, including psychologists who favor talk therapy and doctors who consult widely with drug makers, performed the new analysis, using government grants. The group evaluated six large drug trials, including 728 men and women, about half of them with severe depression and half with more moderate symptoms.
Three of the trials were of Paxil, from GlaxoSmithKline, a so-called S.S.R.I., and the other three were of imipramine, an older generic drug from the class known as tricyclics. The team, led by Jay C. Fournier and Robert J. DeRubeis of the University of Pennsylvania, found that compared with placebos, the drugs caused a much steeper reduction in symptoms of severe depression (cases scoring 25 or higher on a standard scale of severity, putting them in the top quarter of the sample). Patients with scores of less than 25 got little or no added benefit from the medications.
“We were able to give an overall estimate of effectiveness for the first time in this more moderate severity range, from 14 to 20 on the scale, in which there’s no question that doctors would likely consider prescribing medication,” Dr. DeRubeis said.
His co-authors included Steven D. Hollon and Dr. Richard C. Shelton of Vanderbilt University, Sona Dimidjian of the University of Colorado, Dr. Jan Fawcett of the University of New Mexico and Dr. Jay D. Amsterdam of Penn.
The effects of other popular S.S.R.I.’s like Lexapro and Prozac are not likely to be much different than those of Paxil, experts said.
Dr. DeRubeis and others said antidepressants’ inability to outperform placebos against moderate symptoms stemmed partly from the sustained attention that patients in drug trials received from top doctors — which itself can help relieve symptoms, drug or no drug. For some people, too, the drugs’ side effects may cancel any benefit.
“The message for patients with mild to moderate depression,” Dr. DeRubeis said, “is, ‘Look, medications are always an option, but there’s little evidence that they add to other efforts to shake the depression — whether it’s exercise, seeing the doctor, reading about the disorder or going for psychotherapy.’ ”