AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
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.
Depressive Disorder, Major
Drug: Testosterone gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment|
- 21-item Hamilton Depression Rating Scale Score (HAM-D) [ Time Frame: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment) ] [ Designated as safety issue: No ]The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment) ] [ Designated as safety issue: No ]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).
|Study Start Date:||April 2006|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: testosterone gel
AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily
Drug: Testosterone gel
AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
Other Name: AndroGel
Placebo Comparator: placebo gel
Other Name: Placebo
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.
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|The Chaim Sheba Medical Center|
|Tel-Hashomer, Israel, 52621|
|Principal Investigator:||Harrison G Pope, M.D.||Mclean Hospital|
|Principal Investigator:||Stuart N Seidman, M.D.||Columbia University|