The effect of testosterone supplementation on depression symptoms in hypogonadal men from the Testim Registry in the US (TRiUS)

Abstract

Objective: To determine the effect of long-term testosterone replacement therapy (TRT) on depression symptoms in hypogonadal men. Methods: Data were from TRiUS, a multicenter, 12-month observational registry (N = 849) of hypogonadal men prescribed 1% testosterone gel. Measures including total testosterone (TT) were assessed at baseline and months 3, 6, and 12. Depression symptoms were measured with Patient Health Questionnaire-9 (PHQ-9), a validated self-report questionnaire. A PHQ-9 score decrease of ≥5 represents clinical improvement. Results PHQ-9 scores were available for 762/849 TRiUS participants at baseline. Overall, 92.4% (704/762) demonstrated some level of depressive symptoms, with 17.3% (132/762) having moderately severe (score 15–19) to severe (score 20–27) symptoms. Subcohorts with significantly (p ≤ 0.03) more moderately severe to severe symptoms were: <60 years old, TT levels <250 ng/dl (<8.68 nmol/l), HIV/AIDS-positive, or used antidepressants or opioids. TT levels and PHQ-9 scores improved significantly (p < 0.01) by 3 months of TRT. At 12 months PHQ-9 scores showed a clinically meaningful mean improvement of 5.62 points, patients with moderately severe to severe symptoms decreased from 17.3% to 2.1% (5/233), and subcohorts, including those defined by age (<60 years) and antidepressant use, had improved PHQ-9 scores ≥5. Conclusion: TRT may reduce depression symptoms in hypogonadal men, including middle-aged men and those using antidepressants.

Keywords::

• Depression
• Patient Health Questionnaire-9
• Testim
• testosterone gel
• testosterone replacement therapy
• TRiUS

Declaration of interest: Funding for the TRiUS registry, and to support the preparation of this manuscript, was provided by Auxilium Pharmaceuticals, Inc. The authors wish to thank Tara Gupta, PhD of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. Dr. Khera: Allergan: research funding; Auxilium: speaker; Slate: speaker. Dr. Bhattacharya: Amgen: speaker; Auxilium: consultant, steering committee; Bristol-Myers Squibb: speaker; Novartis: speaker; Solvay: speaker. Dr. Blick: Auxilium: investigator, speaker; Tibotec: advisor/consultant, speaker; ViiV: advisor/consultant, speaker; Virxsys: research funding, advisor/consultant. Dr. Kushner: Auxilium: employee. Dr. Nguyen: Auxilium: employee. Dr. Miner: Auxilium: research funding; advisor; Endo: advisor; GlaxoSmithKline: research funding. The data from this analysis were presented as a platform at the American Urological Association 105th Annual Meeting, May 29–June 3, 2010 in San Francisco, California (Khera M et al. J Urol 2010;183(4 suppl):e578. Abstract 1499) and at the International Society of Men’s Health 7th World Congress, 28–30 October 2010 in Nice, France (Miner M et al. J Mens Health 2010;7(3):348. Abstract 213). A paper describing the methodology and baseline demographics and comorbidities of the TRiUS population has been published (Miner MM, Khera M, Bhattacharya R et al. Baseline data from the TRiUS registry: symptoms and comorbidities of testosterone deficiency. Postgrad Med. 2011;123:17–27).