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
About this trial
This is an interventional treatment trial for Gonadal Disorders focused on measuring testosterone, depression, subsyndromal depression, quality of life
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
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
NCT ID
NCT00202462
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
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
Learn more about this trial
The Effect of Testosterone on Mood and Quality of Life
We'll reach out to this number within 24 hrs