The Effect of Testosterone on Mood and Quality of Life

This study has been completed.
Sponsor:
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
First received: September 12, 2005
Last updated: September 30, 2008
Last verified: September 2008
  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.

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SF-36 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Endicott Short Quality of Life Scale [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • SCL-20 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: Testosterone gel
    Testosterone gel 7.5 gm qd
    Other Name: Androgel
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00202462

Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
American Federation for Aging Research
VA Puget Sound Health Care System
Geriatric Research Education and Clinical Care
University of Washington
Solvay Pharmaceuticals
Investigators
Principal Investigator: Molly M Shores, MD University of Washington VA Puget Sound Health Care System, GRECC
  More Information

No publications provided by Seattle Institute for Biomedical and Clinical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
testosterone
depression
subsyndromal depression
quality of life

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 20, 2014