Intramuscular testosterone supplementation to selective serotonin reuptake inhibitor in treatment-resistant depressed men: randomized placebo-controlled clinical trial.
BACKGROUND
Treatment-resistant depression is a persistent clinical problem. Exogenous testosterone therapy has psychotropic effects and has been proposed as an antidepressant supplement, although this strategy has received limited systematic study.


OBJECTIVE
The aim of the study was to examine the mood effects of testosterone supplementation to a serotonergic antidepressant in men with treatment-resistant depression.


METHODS
Twenty-six healthy adult men with major depressive disorder, partial or nonresponse to 2 adequate antidepressant trials during the current episode, and currently using a selective serotonin reuptake inhibitor were randomized under double-blind conditions to receive intramuscular injections of escalating doses of testosterone or placebo, in addition to their existing selective serotonin reuptake inhibitor regimen, for 6 weeks. The main outcome measure was the Hamilton Rating Scale for Depression score.


RESULTS
The mean age was 46.4 +/- 10.8 years; mean total testosterone level, 417.5 +/- 197 ng/dL; mean baseline Hamilton Rating Scale for Depression score, 22.2 +/- 5.2; and median duration of the current depressive episode, 6.3 +/- 10.6 years. Hamilton Rating Scale for Depression scores decreased significantly in both testosterone (8.4) and placebo (7.4) groups. Antidepressant response, defined as a 50% decline in Hamilton Rating Scale for Depression score, was achieved by 53.8% (7/13) in the testosterone group and 23.1% (3/13) in the placebo group (P = 0.226).


CONCLUSIONS
Both injectable testosterone and placebo supplementation to selective serotonin reuptake inhibitor were associated with improvement in mood; group differences were not distinguishable in this small sample of predominantly eugonadal men with treatment-resistant depression.
Seidman
Stuart N
SN
Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY 10032, USA. sns5@columbia.edu
Miyazaki
Marissa
M
Roose
Steven P
SP
D000328:Adult; D000728:Androgens / Q000008:administration & dosage*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011581:Psychological Tests; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage*; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives*
D000728:Androgens; D017367:Selective Serotonin Reuptake Inhibitors; D013739:Testosterone; C004648:testosterone enanthate