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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00260390
• Collaborator: National Alliance for Research on Schizophrenia and Depression (Other)
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysthymic Disorder	Drug: Testoviron	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
• Study Start Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

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) []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Male

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba Medical Center, Psychiatric out patient clinical unit	Tel Hashomer		Israel	52621

Sponsors and Collaborators

• Sheba Medical Center
• National Alliance for Research on Schizophrenia and Depression

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00260390
• Other Study ID Numbers: SHEBA-04-3222-GO-CTIL
• First Posted: Dec 1, 2005
• Last Update Posted: Oct 4, 2006
• Last Verified: Oct 1, 2006

• Keywords provided by , ,: Dysthymic Disorder; HPG hypofunctioning; Testosterone replacement
• Additional relevant MeSH terms: Dysthymic Disorder; Methyltestosterone

Study Results

No Results Posted as of Oct 4, 2006