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

Dysthymic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00260390
• Other study ID #: SHEBA-04-3222-GO-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: November 30, 2005
• Last updated: October 3, 2006
• Start date: September 2004

Study information

• Verified date: October 2006
• Source: Sheba Medical Center
• Contact: Guy Orr, MD
• Phone: 972-52-6666577
• Email: orrg[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysthymic Disorder

Intervention

Drug:
• Testoviron

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Psychiatric out patient clinical unit	Tel Hashomer

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-d)
Primary	Clinical Global Impression- Change (CGI-C)
Primary	Profile of Mood States (POMS)
Primary	Beck Depression Inventory (BDI)
Primary	Sheehan Disability Scale
Primary	Self Anchoring Scale (SAS)
Primary	Affective Balance Scale (ABS)
Primary	International Index of Erectile Function (IIEF)
Primary	Aging Male Symptom rating (AMS)
Primary	Clinical Global Impression (CGI)