Clinical Trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Brief Summary:
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
Detailed Summary:
Sponsor: Sheba Medical Center
Current Primary Outcome:
- Hamilton Depression Scale (HAM-d)
- Clinical Global Impression- Change (CGI-C)
- Profile of Mood States (POMS)
- Beck Depression Inventory (BDI)
- Sheehan Disability Scale
- Self Anchoring Scale (SAS)
- Affective Balance Scale (ABS)
- International Index of Erectile Function (IIEF)
- Aging Male Symptom rating (AMS)
- Clinical Global Impression (CGI)
Original Primary Outcome:
- 1. Hamilton Depression Scale (HAM-d)
- 2. Clinical Global Impression- Change (CGI-C)
- 3. Profile of Mood States (POMS)
- 4. Beck Depression Inventory (BDI)
- 5. Sheehan Disability Scale
- 6. Self Anchoring Scale (SAS)
- 7. Affective Balance Scale (ABS)
- 8. International Index of Erectile Function (IIEF)
- 9. Aging Male Symptom rating (AMS)
- 10. Clinical Global Impression (CGI)
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Sheba Medical Center
Dates:
Date Received: November 30, 2005
Date Started: September 2004
Date Completion:
Last Updated: October 3, 2006
Last Verified: October 2006