The Effect of Testosterone on Mood and Quality of Life
The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression.
3 other identifiers
interventional
33
0 countries
N/A
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.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 1, 2008
September 1, 2008
3.1 years
September 12, 2005
September 30, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale
12 and 24 weeks
Secondary Outcomes (3)
SF-36
12 and 24 weeks
Endicott Short Quality of Life Scale
12 and 24 weeks
SCL-20
12 and 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Age: 50 or older
- Total Testosterone \<=280 ng/dl
- Subsyndromal depressive disorder: either dysthymia or minor depression (per DSM IV and DSM IV appendix)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Institute for Biomedical and Clinical Researchlead
- American Federation for Aging Researchcollaborator
- VA Puget Sound Health Care Systemcollaborator
- Geriatric Research Education and Clinical Carecollaborator
- University of Washingtoncollaborator
- Solvay Pharmaceuticalscollaborator
Related Publications (1)
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.
PMID: 19653976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Molly M Shores, MD
University of Washington VA Puget Sound Health Care System, GRECC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
November 1, 2002
Primary Completion
December 1, 2005
Study Completion
November 1, 2006
Last Updated
October 1, 2008
Record last verified: 2008-09