Testosterone Replacement Therapy for Hypogonadal Men With Major Depressive Disorder: A Randomized, Placebo-Controlled Clinical Trial
J Clin Psychiatry 2001;62:406-412
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Background: Symptoms of male hypogonadism
include low libido, fatigue, and dysphoria and are alleviated
with testosterone replacement. The prevalence of major depressive
disorder (MDD) in hypogonadal men is not known, nor is the
antidepressant efficacy of testosterone replacement in depressed,
Method: A 6-week double-blind,
placebo-controlled clinical trial was conducted in 32 men with
DSM-IV MDD and a low testosterone level, defined as total serum
testosterone <= 350 ng/dL. Patients were randomly assigned to
receive weekly 1-mL intramuscular injections of either
testosterone enanthate, 200 mg, or sesame seed oil (placebo). The
primary outcome measure was the 24-item Hamilton Rating Scale for
Results: Thirty patients were randomly assigned
to an intervention; 13 received testosterone, and 17 received
placebo. Mean ± SD age was 52 ± 10 years, mean testosterone
level was 266.1 ± 50.6 ng/dL, and mean baseline HAM-D score was
21 ± 8. All patients who received testosterone achieved
normalization of their testosterone levels. The HAM-D scores
decreased in both testosterone and placebo groups, and there were
no significant between-group differences: reduction in group mean
HAM-D score from baseline to endpoint was 10.1 in patients who
received testosterone and 10.5 in those who received placebo.
Response rate, defined as a 50% or greater reduction in HAM-D
score, was 38.5% (5/13) for patients who received testosterone
and 41.2% (7/17) for patients who received placebo. Patients
receiving testosterone had a marginal but statistically
significant improvement in sexual function (p = .02).
Conclusion: In this clinical trial with
depressed, hypogonadal men, antidepressant effects of
testosterone replacement could not be differentiated from those