Testosterone versus fluoxetine for depression and fatigue in HIV/AIDS: a placebo-controlled trial.
BACKGROUND
While testosterone's ameliorative effects on depressive disorders and fatigue in HIV-positive patients have been suggested in the literature, no placebo-controlled trial selecting for depressive disorders and including a standard antidepressant has been conducted. Accordingly, this double-blind trial was designed to determine whether testosterone, as well as fluoxetine, is superior to placebo for depression, fatigue, or both.


METHODS
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),


CONCLUSIONS
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.
Rabkin
Judith G
JG
New York State Psychiatric Institute, New York, NY 10032, USA. jgrl@Columbia.edu
Wagner
Glenn J
GJ
McElhiney
Martin C
MC
Rabkin
Richard
R
Lin
Shu Hsing
SH
D000163:Acquired Immunodeficiency Syndrome / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D000328:Adult; D016009:Chi-Square Distribution; D003866:Depressive Disorder / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005221:Fatigue / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013739:Testosterone / Q000627:therapeutic use*
D005473:Fluoxetine; D013739:Testosterone