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| |  Novel Chronic Depression Treatment Study Evaluates Serzone PRINCETON, N.J., Jan. 16, 1997 -- Bristol-Myers Squibb Company (NYSE: BMY) announced today the commencement of an unprecedented chronic depression treatment study which is being conducted at 12 major institutions by some of the nation's most preeminent psychiatrists and psychologists. The multi-center study will compare the safety and efficacy of the company's antidepressant Serzone(R) (nefazodone HCl) to a modified form of psychotherapy specifically designed for chronically depressed patients -- Cognitive Behavior Therapy for the Chronic Depressions (CBT-CD). Serzone and CBT-CD will be evaluated separately and in combination during acute and continuation treatment of patients with chronic major depression and double depression. In addition, the study will include a 52-week maintenance treatment phase to evaluate Serzone versus placebo in the maintenance of clinical response. This will be the first chronic depression study to employ all three treatment approaches during acute treatment -- pharmacotherapy, psychotherapy and combination treatment -- and additionally it includes a maintenance phase with a placebo-control arm. Funded by Bristol-Myers Squibb Company, this $20 million study will evaluate 660 patients over a three-year period. "The realization that major depression is often both chronic and recurrent has slowly begun to change the way depression is diagnosed and treated," said Martin B. Keller, M.D., principal investigator, Brown University, Providence, R.I. "Yet, despite the prevalence of chronic depression and the morbidity and social and vocational impairment associated with chronicity, there has been little systematic study of therapy for chronic forms of depression." The minimal amount of data that is available shows that, in most cases, various forms of psychotherapy are less effective with chronic forms of major depressive disorder than more acute forms of depression. Studies show that depression treatment requires long-term, skillful follow-up and active pharmacotherapy (the use of antidepressant agents). Efficacy and long-term tolerability (lack of sexual dysfunction, sleep disturbance, weight gain and sedation) are important issues when selecting long-term treatments. According to Dr. Keller, "Serzone(R) (nefazodone HCl) was chosen by the collaborating scientists as the medication for this study because it is an efficacious first-line antidepressant with response rates equivalent to selective serotonin reuptake inhibitors (SSRIs). Moreover, the side effect profile is conducive to long-term treatment, exhibiting a negligible incidence of sexual dysfunction, minimal sleep disturbance and very little weight gain." James P. McCullough, Ph.D., principal investigator, Virginia Commonwealth University, Richmond, Va., endeavored to improve the efficacy of one form of psychotherapy -- cognitive behavior therapy (CBT) -- by adapting it to the needs of chronically depressed patients. The CBT-CD method constructed by Dr. McCullough is the only psychotherapy method designed to treat specifically the chronically depressed patient. Serzone is indicated for the treatment of depression. Side effects with Serzone treatment, reported with an incidence of 5 percent or greater and significantly different from placebo, were nausea, somnolence (sedation), dry mouth, dizziness, lightheadedness, constipation, asthenia (weakness or debility), blurred vision, confusion and abnormal vision. Serzone is contraindicated in patients with known hypersensitivity to nefazodone or other phenylpiperazines. Also, co-administration of terfenadine (Seldane(R)), astemizole (Hismanal(R)) and cisapride (Propulsid(R)) with Serzone is contraindicated. Co-administration with monoamine oxidase inhibitors (MAOIs) is not recommended. Dosage reduction of triazolam (Halcion(R)) and alprazolam (Xanax(R)) are recommended when used with Serzone. However, no dosage reduction is required when lorazepam (Ativan(R)) is administered with Serzone. Since any psychoactive drug may impair judgment, thinking or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Serzone therapy does not adversely affect their ability to engage in such activities. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. Visit Bristol-Myers Squibb on the World Wide Web at http://www.bms.com
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