Status:
COMPLETED
The Effect of Testosterone on Mood and Quality of Life
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
American Federation for Aging Research
VA Puget Sound Health Care System
Conditions:
Gonadal Disorders
Depressive Disorder
Eligibility:
MALE
50+ years
Phase:
NA
Brief Summary
We hypothesize that testosterone replacement will improve mood and quality of life in older men with low testosterone and mild depression. Study subjects will receive either testosterone gel or a plac...
Detailed Description
This is a randomized, double-blind, placebo-controlled trial of testosterone replacement in older men with age-associated hypogonadism and subsyndromal depression. Men will receive either 7.5 gm/qd of...
Eligibility Criteria
Inclusion
- Age: 50 or older
- Total Testosterone \<=280 ng/dl
- Subsyndromal depressive disorder: either dysthymia or minor depression (per DSM IV and DSM IV appendix)
Exclusion
- PSA \>=3.0
- Klinefelter's syndrome
- Prostate or breast cancer
- Hospitalized in the past month
- Obstructive BPH
- Current testosterone treatment
- Schizophrenia, bipolar disorder, dementia
- Treatment with antipsychotics or benzodiazepines
- Alcohol dependence or other substance dependence
- Suicidal or psychotic symptoms
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00202462
Start Date
November 1 2002
End Date
November 1 2006
Last Update
October 1 2008
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