- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202462
The Effect of Testosterone on Mood and Quality of Life
The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression.
Study Overview
Status
Conditions
Intervention / Treatment
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 testosterone gel or a placebo gel for 12 weeks. The double-blind phase will be followed by a 12 week open-label extension in which all subjects will receive 7.5 gm/qd of testosterone gel.
Procedures: Depressive symptoms will be assessed with the Hamilton Depression Rating Scale (HDRS) and the SCL-20, a 20-item self-report depression scale that has been shown to have high reliability and validity and to be sensitive to changes in depressive symptoms in outpatients in primary care settings. The short form (16 item) Endicott Quality of Life Enjoyment and Satisfaction Scale will be used to assess quality of life changes. The Medical Outcomes Study Short-Form 36 (SF-36) will be used to assess changes in functional status. Demographic information, medical history and current medications will be determined at baseline and follow up, via patient interview and chart review. Overall medical morbidity will be ascertained with the Cumulative Illness Rating Scale. All outcome measures (SCL-20, Endicott Quality of Life Scale, HDRS,SF-36) will be assessed at baseline, week 12 (end of the double-blind phase)and week 24 (end of the extension phase). Blood draws will be done at baseline, week 12 and week 24. Laboratory assays for testosterone leves at baseline, week 12 and week 24 will be performed at the same time to minimize interassay variability.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Rating Scale
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
SF-36
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
Endicott Short Quality of Life Scale
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
SCL-20
Time Frame: 12 and 24 weeks
|
12 and 24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Molly M Shores, MD, University of Washington VA Puget Sound Health Care System, GRECC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDIS 0004
- AFAR: A02034
- Solvay:UMD-02-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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