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

Phase 4

Completed

Brief 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.

Detailed Description: We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
testosterone gel	Testosterone gel	AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily
placebo gel	Placebo	Placebo gel

Primary Outcome Measures

Name	Time	Method
21-item Hamilton Depression Rating Scale Score (HAM-D)	9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)	The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).

Secondary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale (MADRS)	9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)	The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).