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