A randomized, double-blind, placebo-controlled study of testosterone treatment in hypogonadal older men with subthreshold depression (dysthymia or minor depression).

OBJECTIVE: Hypogonadism and subthreshold depression are common conditions in elderly men. The objective of this study was to examine the effect of testosterone treatment in older, hypogonadal men with subthreshold depression.

METHOD: A randomized, double-blind, placebo-controlled study was conducted at a university-affiliated Veterans Affairs Medical Center among men aged 50 years or older (N = 33) with screening total testosterone levels of
RESULTS: At the end of the double-blind phase, testosterone-treated men had a greater reduction in HAM-D scores (p = .024) and a higher remission rate of subthreshold depression (52.9% vs. 18.8%, p = .041) than did placebo-treated men, but there were no differences in other secondary outcome measures between groups. At the end of the open-label phase, the testosterone group had sustained improvement, the control group improved, and there were no differences between groups in any outcome measures.

CONCLUSION: These results suggest that testosterone replacement may be efficacious treatment for subthreshold depression in older men with hypogonadism. Larger studies are needed to corroborate these findings.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00202462.