AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Collaborator: Solvay Pharmaceuticals
• Treatments: Antidepressive Agents; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Male

• 30-65 years old

• Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year

• HAM-D score >12

Exclusion Criteria:

• Current suicidal ideation

• Substance abuse or dependence within the past year

• Current or past psychotic symptoms

• A history of bipolar disorder

• A prostate-specific antigen (PSA) level greater than 4.0 ng/ml

• Other clinically significant medical condition

• A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.