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The Effect of Testosterone on Mood and Quality of Life

Primary Purpose

Gonadal Disorders, Depressive Disorder, Hypogonadism

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Testosterone gel
Sponsored by
Seattle Institute for Biomedical and Clinical Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonadal Disorders focused on measuring testosterone, depression, subsyndromal depression, quality of life

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Hamilton Depression Rating Scale

    Secondary Outcome Measures

    SF-36
    Endicott Short Quality of Life Scale
    SCL-20

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 30, 2008
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00202462
    Brief Title
    The Effect of Testosterone on Mood and Quality of Life
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the 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

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.)
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gonadal Disorders, Depressive Disorder, Hypogonadism
    Keywords
    testosterone, depression, subsyndromal depression, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Testosterone gel
    Other Intervention Name(s)
    Androgel
    Intervention Description
    Testosterone gel 7.5 gm qd
    Primary Outcome Measure Information:
    Title
    Hamilton Depression Rating Scale
    Time Frame
    12 and 24 weeks
    Secondary Outcome Measure Information:
    Title
    SF-36
    Time Frame
    12 and 24 weeks
    Title
    Endicott Short Quality of Life Scale
    Time Frame
    12 and 24 weeks
    Title
    SCL-20
    Time Frame
    12 and 24 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Molly M Shores, MD
    Organizational Affiliation
    University of Washington VA Puget Sound Health Care System, GRECC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19653976
    Citation
    Shores MM, Kivlahan DR, Sadak TI, Li EJ, Matsumoto AM. A randomized, double-blind, placebo-controlled study of testosterone treatment in hypogonadal older men with subthreshold depression (dysthymia or minor depression). J Clin Psychiatry. 2009 Jul;70(7):1009-16. doi: 10.4088/jcp.08m04478.
    Results Reference
    derived

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