The Effect of Testosterone on Mood and Quality of Life

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

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 placebo (inactive) gel for 12 weeks. Neither the subject or the investigator will know whether they are receiving placebo or testosterone gel. At the end of the initial 12 week period, all subjects will receive testosterone gel for 12 more weeks. Mood and quality of life measures will be obtained at baseline, at the end of the double-blind phase and at the end of the extension phase (when all subjects receive testosterone.)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: American Federation for Aging Research; Geriatric Research Education and Clinical Care; Solvay Pharmaceuticals; University of Washington; VA Puget Sound Health Care System
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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