Abstract | BACKGROUND: METHOD: One hundred twenty-three men with HIV/ AIDS with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition depressive disorder entered the 8-week trial and were randomized to testosterone (up to 400 mg IM testosterone cypionate biweekly), fluoxetine (up to 60 mg/d), or double placebo. Outcome variables were the Clinical Global Impressions Scale for mood and for fatigue, the Hamilton Rating Scale for Depression, and the Chalder Fatigue Scale. RESULTS: Ninety men completed the trial. In intention-to-treat analyses, mood response rates were 54%, 47%, and 44% for fluoxetine, testosterone, and placebo, respectively. Among completers, mood response rates were 70%, 57%, and 53%, respectively; in neither analysis were differences between treatments statistically significant. In contrast, testosterone was superior to fluoxetine and placebo for completers regarding fatigue. In intention-to-treat analysis, response rates were 39%, 56%, and 42% for fluoxetine, testosterone, and placebo, respectively, and for study completers, 41%, 63%, and 52%, respectively, (P < 0.05), CONCLUSION: While over 50% of patients treated with testosterone reported improved mood, this rate was not statistically superior to placebo. Thus, our findings do not support prescription of testosterone as a first-line treatment for depressive disorders in HIV-positive men. However, if validated in additional studies, testosterone may be a useful option for medically ill men experiencing significant fatigue as well as depression.
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Authors | Judith G Rabkin, Glenn J Wagner, Martin C McElhiney, Richard Rabkin, Shu Hsing Lin |
Journal | Journal of clinical psychopharmacology
(J Clin Psychopharmacol)
Vol. 24
Issue 4
Pg. 379-85
(Aug 2004)
ISSN: 0271-0749 [Print] United States |
PMID | 15232328
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Copyright | Copyright 2004 Lippincott Williams and Wilkins |
Chemical References |
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Topics |
- Acquired Immunodeficiency Syndrome
(complications, drug therapy, psychology)
- Adult
- Chi-Square Distribution
- Depressive Disorder
(complications, drug therapy, psychology)
- Double-Blind Method
- Fatigue
(complications, drug therapy, psychology)
- Fluoxetine
(therapeutic use)
- Humans
- Male
- Middle Aged
- Testosterone
(therapeutic use)
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