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

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Depressive Disorder, Major

Treatments

Drug: Placebo

Drug: Testosterone gel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00304746

2005P-001667

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Male

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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.