Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment.
Exogenous testosterone therapy has psychotropic effects and has been proposed as an antidepressant augmentation strategy for depressed men. We sought to assess the antidepressant effects of testosterone augmentation of a serotonergic antidepressant in depressed, hypogonadal men. For this study, we recruited 100 medically healthy adult men with major depressive disorder showing partial response or no response to an adequate serotonergic antidepressant trial during the current episode and a screening total testosterone level of 350 ng/dL or lower. We randomized these men to receive testosterone gel or placebo gel in addition to their existing antidepressant regimen. The primary outcome measure was the Hamilton Depression Rating Scale (HDRS) score. Secondary measures included the Montgomery-Asberg Depression Rating Scale, the Clinical Global Impression Scale, and the Quality of Life Scale. Our primary analysis, using a mixed effects linear regression model to compare rate of change of scores between groups on the outcome measures, failed to show a significant difference between groups (mean [95% confidence interval] 6-week change in HDRS for testosterone vs placebo, -0.4 [-2.6 to 1.8]). However, in one exploratory analysis of treatment responders, we found a possible trend in favor of testosterone on the HDRS. Our findings, combined with the conflicting data from earlier smaller studies, suggest that testosterone is not generally effective for depressed men. The possibility remains that testosterone might benefit a particular subgroup of depressed men, but if so, the characteristics of this subgroup would still need to be established.
Pope
Harrison G
HG
Biological Psychiatry Laboratory, McLean Hospital, Belmont, MA 02478, USA. hpope@mclean.harvard.edu
Amiaz
Revital
R
Brennan
Brian P
BP
Orr
Guy
G
Weiser
Mark
M
Kelly
John F
JF
Kanayama
Gen
G
Siegel
Arthur
A
Hudson
James I
JI
Seidman
Stuart N
SN
D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000097:blood / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology*; D004311:Double-Blind Method; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life / Q000523:psychology; D016037:Single-Blind Method; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood; D016896:Treatment Outcome
D000928:Antidepressive Agents; D005782:Gels; D013739:Testosterone