Depressive Syndromes in Men With Hypogonadism in the TRAVERSE Trial: Response to Testosterone-Replacement Therapy
Authors' conclusion
Depressive symptoms are common in middle-aged and older men with hypogonadism but LG-PDD is uncommon. TRT is associated with small improvements in mood and energy in hypogonadal men with and without significant depressive symptoms.
Study context
- Population
- Men aged 45–80 years with 2 fasting testosterone levels <300 ng/dL, ≥1 hypogonadal symptom, and cardiovascular disease (CVD) or increased CVD risk; subgroups: Low-grade persistent depressive disorder (LG-PDD), significant depressive symptoms (PHQ-9 >4), all randomized menrandomized
- Participants
- 5,204 men
- Comparison
- 1.62% transdermal testosterone vs placebo gel
Methodological detailsrandomized, placebo-controlled, double-blind, 316 trial sites
- Randomized
- Placebo-controlled
- Double-blind
- 316 trial sites
Primary result
As reported in the abstract
Depressive outcomes by subgroup
- LG-PDD (n=49): no significant difference in any outcome measure between testosterone-replacement therapy (TRT) and placebo, possibly reflecting low statistical power
- Significant depressive symptoms (n = 2643): TRT associated with modest but significantly greater improvements in mood and energy, but not cognition or sleep quality
- All randomized (n = 5204): TRT associated with modest but significantly greater improvements in mood and energy, but not cognition or sleep quality
Further findings
Prevalence of significant depressive symptoms and LG-PDD at baseline
- Significant depressive symptoms
- 2643 (50.8%)
- Met rigorous criteria for LG-PDD
- 49 (1.5%)
Original publication
Depressive Syndromes in Men With Hypogonadism in the TRAVERSE Trial: Response to Testosterone-Replacement Therapy. J Clin Endocrinol Metab. Published 11 January 2024. doi:10.
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