At a glance
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A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment
In Brief
A Phase 4 clinical trial evaluating Testosterone gel and Placebo for Depressive Disorder, Major. Completed, enrolled 100 participants across 2 sites in 2 countries.
Detailed Summary
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.
Study Details
Timeline
Interventions
AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
Placebo