Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

• ClinicalTrials.gov Identifier: NCT00260390
• Recruitment Status: Unknown
• First Posted: December 1, 2005
• Last Update Posted: October 4, 2006
• Sponsor: Sheba Medical Center
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Information provided by: Sheba Medical Center

Tracking Information

• First Submitted Date: November 30, 2005
• First Posted Date: December 1, 2005
• Last Update Posted Date: October 4, 2006
• Study Start Date: September 2004
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: October 3, 2006)

• 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 Measures (submitted: November 30, 2005)

• 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 Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Dysthymic Disorder
• Intervention: Drug: Testoviron
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

1. Male, age 40-80 years.
2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
3. Diagnosis of Dysthymic disorder with onset after age 40.
4. PSA < 4.0.
5. Normal digital exam of the prostate in the preceding 1 year.
6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
7. Able to give informed consent.

Exclusion Criteria:

1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
2. Currently being treated with testosterone.
3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
4. Current suicidal risk.
5. Current (past year) substance abuse or dependence.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00260390
• Other Study ID Numbers: SHEBA-04-3222-GO-CTIL
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Sheba Medical Center
• Original Study Sponsor: Same as current
• Collaborators: National Alliance for Research on Schizophrenia and Depression

Investigators

• Principal Investigator: Guy Orr, MD; Sheba Medical Center

• PRS Account: Sheba Medical Center
• Verification Date: October 2006