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Embargoed until May 28, 1998
UCSD RESEARCH SUGGESTS NEW HOPE FOR HIV POSITIVE PATIENTS WITH DEPRESSION
SAN DIEGO, May 25, 1998 - A study published in the May 28 issue of the Journal of Clinical Psychiatry demonstrates that Prozac (fluoxetine hydrochloride) in combination with group therapy is more effective than group therapy alone in treating HIV-positive patients diagnosed with major depression. The study, among the first to compare the effectiveness of selective serotonin re-uptake inhibitor antidepressants like Prozac against psychotherapy, also shows that Prozac did not interact significantly with any HIV medications and produced minimal side effects. Results of the study might lead to better compliance by patients already taking multiple drug therapies, according to Sidney Zisook, M.D., professor of psychiatry with UCSD School of Medicine and lead author of the study.
Major depressive episodes are estimated to be present in 7 to 20 percent of all HIV-positive patients. HIV patients often suffer multiple medical complications and tend to receive a number of potentially toxic medications during the course of their illness.
"They can ill afford to receive yet another medication unless the treatment is safe," said Zisook.
The randomized, double blind, placebo-controlled study examined 47 HIV positive men who were seen in weekly supportive group therapy. The sample consisted of men who had recurrent major depression and whose present episode had been continuing for at least several months. On average, patients had been HIV positive for about three years prior to entry into the study. Twenty-five patients were given up to 60 mg of Prozac during the seven week trial. Twenty-two patients received a placebo.
Researchers found statistically significant differences favoring group psychotherapy plus Prozac over group psychotherapy plus placebo. Patients treated with Prozac experienced a two-fold improvement in baseline depression rating scales (12.1 for subjects given Prozac vs. 6.6 for subjects given the placebo.) A greater percentage of patients in the Prozac group (64 percent vs. 23 percent) experienced a reduction of at least 50 percent in depression rating scores. Similarly, the percentage of patients who were rated as either very much improved or much improved was higher (64 percent vs. 48 percent) in the Prozac group.
Among patients rated as severely depressed, those treated with psychotherapy plus Prozac appeared to do significantly better than those treated with psychotherapy and placebo. Patients rated as mild to moderately depressed appeared to do equally well whether treated with psychotherapy and Prozac or psychotherapy and placebo.
"As the HIV epidemic continues to spread world wide, more HIV positive men and women with depression can expect to require treatment," said Dr. Zisook. "Patients who are HIV positive and experience depression can and do respond to antidepressant treatment."
Factors that may contribute to the onset of a major depression in patients with HIV include isolation from social supports, occupational disability, alterations in body image, bereavement, loss of friends, debilitation, effects of HIV virus on the brain, and the knowledge of having a terminal illness.
Although patients were taking antiretroviral agents such as AZT, the study was completed before the widespread use of protease inhibitors. No serious drug interactions involving the combination of protease inhibitors and SSRIs have been reported. However, the potential for drug interactions does exist. Since all patients were treated with group psychotherapy, the study is not considered a true placebo study. Several smaller studies have supported the effectiveness of group psychotherapy for treating HIV-associated depression.
Co-authors on the study are Joanna Peterkin, M.D., and Kathleen J. Goggin, Ph.D., both of the New York State Psychiatric Institute and Cornell University Medical College; Paul Sledge, Ph.D., California State University, San Marcos; and J. Hampton Atkinson, M.D. and Igor Grant, M.D., both of UCSD School of Medicine.
The study was supported by the HIV Neurobehavioral Research Center at UCSD School of Medicine and by Eli Lilly and Company.
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