May 24, 2000 PROVIDENCE, R.I. (May 17, 2000) — A new study published today in the New England Journal of Medicine shows that a combination therapy of the antidepressant Serzone and psychotherapy designed specifically for chronic depression provides the best treatment for patients with chronic forms of major depression.
For the 681 patients in the study, this two-fisted approach produced an 85-percent response rate, the highest such rate for a three-month period for any reported study of depression.
“This is the first time that combination therapy has proven to be so much more effective than either medication or psychotherapy alone,” said lead investigator Martin B. Keller, M.D. “For some of the study’s patients, who underwent the combination therapy, it was the first time in more than 20 years that they could sustain pleasure and function fully at work and with families and friends.”
The study is the largest ever undertaken of medication alone, psychotherapy alone and an aggregate of the two, to treat chronic forms of major depression. The psychotherapy was designed specifically to treat chronic types of depression. Bristol-Myers Squibb Co., makers of Serzone, funded the research.
An estimated 14 million Americans suffer from chronic forms of depression, marked by severely disabling psychological and social problems. Annually, more than 46 million Americans, ages 15-54, suffer from depressive episodes. Depression costs the U.S. economy an estimated $53 billion each year.
The study took place at a dozen outpatient psychiatric clinics and academic medical centers nationwide. Patients had been depressed continuously for at least two years. On average, their condition was chronic for nearly 20 years. Patients were randomized to receive either Serzone twice daily, 16 to 20 sessions of Cognitive Behavioral Analysis System of Psychotherapy (CBASP), or a combination of both, over a 12-week period.
During the initial 12-week acute phase of the 80-week study, the combination of Serzone and psychotherapy produced an 85-percent response rate. The drug alone led to a 55-percent rate of response, similar to a 52-percent response rate for the psychotherapy alone. Serzone is currently used to treat depression and is effective for reducing relapse, but it is not labeled for use in treating chronic forms of the illness.
“The findings offer hope for the vast number of patients suffering from chronic forms of major depression,” Keller said. “The study also underscores the importance of treating patients with combination therapy. These patients are often considered poorly responsive to treatment. That’s why they rarely receive a complete course of either medication or psychotherapy. But the study shows that these individuals are not resistant to medication and psychotherapy.”
Keller is the Mary E. Zucker professor and chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine. He and most of the other principal investigators in the study were consultants and received honorariums from Bristol-Myers Squibb, or serve on the company’s Scientific Advisory Board. Most of these researchers also have similar relationships with other firms that manufacture FDA-approved treatments for depression.
In the study, Serzone, alone or in combination therapy, was associated with improvement in patients much sooner than psychotherapy. In addition, patients did not experience significant sexual dysfunction or weight gain, frequent side effects with antidepressants. Compared to the psychotherapy, Serzone was also shown to provide significant improvement in insomnia, which is common in chronically depressed patients.
The research included a 16-week continuation trial for patients who responded positively to Serzone or to the combination treatment in the acute phase followed by a 52-week maintenance treatment to evaluate the drug versus a placebo.
The psychotherapy used in the study is a structured, intensive program developed by James P. McCullough of Virginia Commonwealth University. Drawing on techniques of other psychotherapies, CBASP teaches patients to focus on the consequences of their behavior and use a problem-solving approach to address problematic interpersonal difficulties.
The results for either of the single treatments in the study, Serzone or CBASP were similar to those found for antidepressants in previous studies of patients with chronic forms of major depression. However, the results cannot be extrapolated to any other antidepressant used in combination with psychotherapy or other less structured forms of psychotherapy, unless they have been studied in clinical trials and demonstrated similar rates of response, Keller said.
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