Depressive Syndromes in Men With Hypogonadism in the TRAVERSE Trial: Response to Testosterone-Replacement Therapy

Author:

Bhasin Shalender1ORCID,Seidman Stuart2,Travison Thomas G3,Pencina Karol M1,Lincoff A Michael4,Nissen Steven E4,Miller Michael G5,Flevaris Panagiotis5,Li Xue5,Wannemuehler Kathleen A6,Pope Harrison G78ORCID

Affiliation:

1. Research Program in Men's Health: Aging and Metabolism, Boston Claude D. Pepper Older Americans Independence Center, Brigham and Women's Hospital, Harvard Medical School , Boston, MA 02115 , USA

2. New York , NY 10024 , USA

3. Marcus Institute for Aging Research, Hebrew Senior Life, Division of Gerontology, Beth Israel Deaconess Medical Center, Harvard Medical School , Boston, MA 02131 , USA

4. Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Department of Cardiovascular Medicine, Cleveland Clinic , Cleveland, OH 44195 , USA

5. AbbVie Inc , North Chicago, IL 60064 , USA

6. Statistical Data Analysis Center, Department of Biostatistics and Medical Informatics, University of Wisconsin–Madison , Madison, WI 53706 , USA

7. Biological Psychiatry Laboratory, McLean Hospital , Belmont, MA 02478 , USA

8. Harvard Medical School , Boston, MA 02115 , USA

Abstract

Abstract Context The effect of testosterone on depressive symptoms in men with hypogonadism remains incompletely understood. Objective We assessed the effects of testosterone-replacement therapy (TRT) in improving depressive symptoms in hypogonadal men with and without depressive symptoms enrolled in the TRAVERSE cardiovascular safety trial. Methods A randomized, placebo-controlled, double-blind study was conducted at 316 trial sites. Participants included men, aged 45 to 80 years, with 2 fasting testosterone levels less than 300 ng/dL, 1 or more hypogonadal symptoms, cardiovascular disease (CVD), or increased risk of CVD. We evaluated 3 subgroups of participants: (1) men with rigorously defined, late-life-onset, low-grade persistent depressive disorder (LG-PDD, previously “dysthymia”); (2) all men with significant depressive symptoms (Patient Health Questionnaire-9 Score >4); and (3) all randomly assigned men. Intervention included 1.62% transdermal testosterone or placebo gel. Outcome measures included the proportions of participants (1) meeting criteria for LG-PDD or (2) with significant depressive symptoms; and changes in depressive symptoms, energy, sleep quality, and cognition in testosterone-treated vs placebo-treated men in the 3 subgroups. Results Of 5204 randomly assigned participants, 2643 (50.8%) had significant depressive symptoms, but only 49 (1.5%) met rigorous criteria for LG-PDD. Among those with LG-PDD, there was no significant difference in any outcome measure between the TRT and placebo groups, possibly reflecting low statistical power. In men with significant depressive symptoms (n = 2643) and in all randomly assigned participants (n = 5204), TRT was associated with modest but significantly greater improvements in mood and energy but not cognition or sleep quality. 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.

Funder

AbbVie, Inc

Endo Pharmaceuticals

Acerus Pharmaceuticals Corporation

Upsher-Smith Laboratories, LLC

Boston Claude D. Pepper Older Americans Independence Center

Publisher

The Endocrine Society

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1. Safety, efficacy, and pharmacokinetics of oral testosterone undecanoate in males with hypogonadism;Andrology;2024-09-10

2. Testosterone deficiency and chronic kidney disease;Journal of Clinical & Translational Endocrinology;2024-09

3. Lessons learned from the TRAVERSE trial;The Journal of Sexual Medicine;2024-09

4. Testosterone and male contraception;Current Opinion in Endocrinology, Diabetes & Obesity;2024-08-20

5. Testosterone therapy in older men: clinical implications of recent landmark trials;European Journal of Endocrinology;2024-06-26

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