98-125 (Nefazodone Study)
Brown University News Bureau

The Brown University News Bureau

Distributed May 18, 1999
Contact: Scott Turner

Evidence shows drug-psychotherapy combo effective for chronic depression
Preliminary results from the largest study undertaken of medication alone, psychotherapy alone and a combination of the two, to treat chronic depression, show that medication and psychotherapy together works best.

WASHINGTON, D.C. -- A new combination of drug treatment and psychotherapy is much more effective than either medication or therapy alone for treating chronic depression, according to preliminary results presented Tuesday, May 18, at the annual meeting of the American Psychiatric Association.

The combination treatment, involving the drug nefazodone and a form of psychotherapy developed specifically to treat chronic depression, also produced the highest response and remission rates for any reported study of chronic depression.

The findings come from the Serzone Chronic Depression Study, the first major study of medication alone, psychotherapy alone, and the combination of both in patients with chronic depression. Nefazodone, prescribed under the brand name Serzone, is used to treat depression and is effective for reducing relapse. The research is funded by Bristol-Myers Squibb Company, makers of Serzone.

Results from the acute phase - the first 12 weeks - of the 80-week study of 681 patients depressed for at least two years shows that a combination of nefazodone and psychotherapy produces an 85 percent response rate. The drug alone leads to a 55 percent rate of response, similar to a 52 percent response rate for psychotherapy.

Nefazodone, alone or in combination therapy, was also associated with improvement in patients much sooner than psychotherapy. The drug also provided significant early and ongoing improvement in insomnia, which is common in chronically depressed patients.

"The extremely large difference in response rates after 12 weeks is truly astonishing," said lead researcher Martin B. Keller, M.D. "This study should put to rest the widespread belief that chronic depression is resistant to drug treatments and psychotherapy." Keller is professor and chairman of the Department of Psychiatry and Human Behavior in the Brown University School of Medicine.

The study involves individuals treated at outpatient psychiatric clinics at 12 academic medical centers. The research includes a 16-week continuation trial for patients who respond positively to nefazodone or to the combination treatment in the acute phase followed by a 52-week maintenance treatment to evaluate the drug versus a placebo.

"The evidence now exists that the combination of psychotherapy with nefazodone gives very substantial benefits," Keller said. "We need to strongly consider that people with chronic depression, a condition they have suffered most of their adult lives, should be receiving this treatment combination to maximize the likelihood they will respond."

About three percent of the population suffers from chronic forms of depression, marked by disabling psychological and social problems. These individuals are often misdiagnosed as having character or personality disorders.

"The next step is to translate the acute phase findings into appropriate treatment guidelines for initial management of chronic depression," Keller said. "The data that will emerge from the continuation and maintenance phases will be extremely helpful in developing long-term treatment guidelines for managing patients with chronic depression."

The effectiveness of nefazodone alone for treating chronic depression is similar to that reported for the antidepressants sertraline, imipramine and desipramine. But the study results cannot be extrapolated to any other antidepressant used in combination with psychotherapy or other less structured forms of psychotherapy, Keller said.

The psychotherapy used in the study is a structured, intensive program, developed by James P. McCullough of Virginia Commonwealth University and called Cognitive Behavioral Analysis System of Psychotherapy (CBASP).

"We need to consider which psychotherapies need to be given to people suffering from chronic depression," Keller said. "We have very strong evidence that a structured, cognitive-based therapy is very effective. We hope this will lead to more people in the fields of psychiatry and psychology being trained in proven treatments and more chronically depressed people receiving these treatments so response rates will be higher."

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