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| Sponsor: | Seattle Institute for Biomedical and Clinical Research |
|---|---|
| Collaborators: |
American Federation for Aging Research VA Puget Sound Health Care System Geriatric Research Education and Clinical Care University of Washington Solvay Pharmaceuticals |
| Information provided by: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00202462 |
Purpose
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.)
| Condition | Intervention |
|---|---|
|
Gonadal Disorders Depressive Disorder Hypogonadism |
Drug: Testosterone gel |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression. |
| Enrollment: | 33 |
| Study Start Date: | November 2002 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Molly M Shores, MD | University of Washington VA Puget Sound Health Care System, GRECC |
More Information
| Responsible Party: | Molly Shores, MD, VA Puget Sound Health Care System |
| ClinicalTrials.gov Identifier: | NCT00202462 History of Changes |
| Other Study ID Numbers: | RDIS 0004, AFAR: A02034, Solvay:UMD-02-097 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 30, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
testosterone depression subsyndromal depression quality of life |
|
Depressive Disorder Depression Gonadal Disorders Hypogonadism Mood Disorders Mental Disorders Behavioral Symptoms Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate |
Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |