Trial record 39 of 2860 for: Rating | "Depressive Disorder"
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00304746|
Recruitment Status : Completed
First Posted : March 20, 2006
Results First Posted : November 17, 2010
Last Update Posted : November 24, 2010
Information provided by:
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Depressive Disorder, Major
Drug: Testosterone gel
|Recruitment Details||The study was conducted at two sites – McLean Hospital in Belmont Massachusetts, USA and the Chaim Sheba Medical Center in Tel Hashomer, Israel. Using advertisements at each site, we recruited men age 30-65 with major depressive disorder incompletely responsive to a serotonergic antidepressant, and showing a total testosterone level ≤ 350 ng/dL.|
|Pre-assignment Details||At baseline, participants began a 1-week, single-blind placebo lead-in of one packet of placebo gel daily. Men exhibiting ≥ 50% improvement on either the Hamilton Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.|
The small number of participants limited statistical power. Also, the study recruited “treatment-resistant” men, who are often poorly responsive. For a detailed discussion, see the published report of the study.