The Effect of Testosterone on Mood and Quality of Life

Depressive Disorder Clinical Trial

Official title:

The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202462
• Other study ID #: RDIS 0004
• Secondary ID: AFAR: A02034Solv
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 30, 2008
• Start date: November 2002
• Est. completion date: November 2006

Study information

• Verified date: September 2008
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Disease
• Gonadal Disorders
• Hypogonadism

Intervention

Drug:
• Testosterone gel
Testosterone gel 7.5 gm qd

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	American Federation for Aging Research, Geriatric Research Education and Clinical Care, Solvay Pharmaceuticals, University of Washington, VA Puget Sound Health Care System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale		12 and 24 weeks	No
Secondary	SF-36		12 and 24 weeks	No
Secondary	Endicott Short Quality of Life Scale		12 and 24 weeks	No
Secondary	SCL-20		12 and 24 weeks	No