Status:
COMPLETED
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Solvay Pharmaceuticals
Conditions:
Depressive Disorder, Major
Eligibility:
MALE
30-65 years
Phase:
PHASE4
Brief Summary
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....
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00304746
Start Date
April 1 2006
End Date
April 1 2009
Last Update
November 24 2010
Active Locations (2)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
The Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621