AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|