TREATMENT OF MAJOR DEPRESSION IN HIV-SEROPOSITIVE MEN

Background: The purpose of this randomized double-blind, placebo-contr olled study was to compare the efficacy and safety of fluoxetine plus group psychotherapy versus group psychotherapy alone in HIV-seropositi ve men Chased on 1986 CDC classes II, III, and IV.C.2) who had been di agnosed 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 psychot herapy. In addition, subjects were rated on the 17-item Hamilton Ratin g Scale for Depression (HAM-D-17), 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 gi ven placebo. Results: Subjects who received fluoxetine began to show s ignificantly more improvement than patients who received placebo on bo th self-than observer-rated scales by the end of the first week of tre atment. By endpoint, patients treated with fluoxetine experienced grea ter 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-1 3 (5.9 vs. 1.2; F = 5.73, df = 1,45; p < .05), and a greater percentag e of fluoxetine-treated patients experienced a greater than or equal t o 50% in HAM-D-17 scores (64% vs. 23%; chi(2) = 8.60, df = 1, p < .01) . Differences were particularly apparent in subjects whose initial dep ressive episodes were rated as severe (i.e., HAM-D-17 score greater th an or equal to 24). Severely depressed patients treated with fluoxetin e 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). Furt her, side effects were generally mild and transient. The most frequent ly noted effects reported by subjects treated with fluoxetine were nau sea, dry mouth, headache, and diarrhea, in decreasing order of frequen cy. Conclusion: This study supports the efficacy and safety of fluoxet ine over and above group psychotherapy for the treatment of HN-associa ted major depression.