Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202462
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2005-09-12
Brief Title:
The Effect of Testosterone on Mood and Quality of Life
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
The Effect of Testosterone Treatment on Depressive Symptoms and Quality of Life in Older Men With Age-Related Hypogonadism and Subsyndromal Depression
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 75 gmqd 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 75 gmqd 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 HDRSSF-36 will be assessed at baseline week 12 end of the double-blind phaseand 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
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 HDRSSF-36 will be assessed at baseline week 12 end of the double-blind phaseand 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SolvayUMD-02-097 | None | None | None |
| AFAR A02034 | None | None | None |