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The Effect of Testosterone on Mood and Quality of Life

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ClinicalTrials.gov Identifier: NCT00202462
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 1, 2008
Information provided by:

Study Description
Brief 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.)

Condition or disease Intervention/treatment
Gonadal Disorders Depressive Disorder Hypogonadism Drug: Testosterone gel

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : November 2002
Primary Completion Date : December 2005
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: 12 and 24 weeks ]

Secondary Outcome Measures :
  1. SF-36 [ Time Frame: 12 and 24 weeks ]
  2. Endicott Short Quality of Life Scale [ Time Frame: 12 and 24 weeks ]
  3. SCL-20 [ Time Frame: 12 and 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Molly M Shores, MD University of Washington VA Puget Sound Health Care System, GRECC
More Information

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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 1, 2008
Last Verified: September 2008

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

Additional relevant MeSH terms:
Depressive Disorder
Gonadal Disorders
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents