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

Completed · Phase 4 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID: NCT00304746
Run by: Mclean Hospital
People needed: 100
Starts: 2006-04-01
Expected to finish: 2009-04-01
Last updated by the study team: 2010-11-24

Who can join

Age: 30 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

McLean Hospital — Belmont, Massachusetts, United States
The Chaim Sheba Medical Center — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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