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Article Abstract

Background: The purpose of this randomized doubleblind, placebo-controlled study was to compare the efficacy and safety of fluoxetine plus group psychotherapy versus group psychotherapy alone in HIV-seropositive men (based on 1986 CDC classes II, III, and IV.C.2) who had been diagnosed with major depressive disorder (DSM-III-R).

Method: During a 7-week trial, patients were treated with fluoxetine 20_60 mg or placebo 1_3 capsules per day and were seen in weekly supportive group psychotherapy. In addition, subjects were rated on the 17item Hamilton Rating Scale for Depression (HAM-D17), Clinical Global Impressions scales for Improvement (CGI-I) and Severity of Illness (CGI-S), and the short version of the Beck Depression Inventory (BDI-13). Of the 47 patients enrolled in the study, 25 were administered fluoxetine and 22 were given placebo.

Results: Subjects who received fluoxetine began to show significantly more improvement than patients who received placebo on both self- and observer-rated scales by the end of the first week of treatment. By endpoint, patients treated with fluoxetine experienced greater mean changes from baseline compared with placebo-treated patients on the HAM-D-17 (12.1 vs. 6.6; F=6.53, df=1,45; p<.05) and BDI-13 (5.9 vs. 1.2; F=5.73, df=1,45; p<.05), and a greater percentage of fluoxetine-treated patients experienced a ž50% in HAM-D-17 scores (64% vs. 23%; c2=8.60, df=1, p<.01). Differences were particularly apparent in subjects whose initial depressive episodes were rated as severe (i.e., HAM-D-17 scorež24). Severely depressed patients treated with fluoxetine had an endpoint CGI-I of 1.4 compared with an endpoint CGI-I of 2.7 for patients treated with placebo (F=6.02, df=1,11; p<.05). Further, side effects were generally mild and transient. The most frequently noted effects reported by subjects treated with fluoxetine were nausea, dry mouth, headache, and diarrhea, in decreasing order of frequency.

Conclusion: This study supports the efficacy and safety of fluoxetine over and above group psychotherapy for the treatment of HIVassociated major depression.

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