AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
|ClinicalTrials.gov Identifier: NCT00304746|
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : November 17, 2010
Last Update Posted : November 24, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Testosterone gel Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||April 2009|
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
- 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) ]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) ]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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304746
|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|