Status:
UNKNOWN
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Lead Sponsor:
Sheba Medical Center
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Dysthymic Disorder
Eligibility:
MALE
40-80 years
Phase:
PHASE4
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 Test...
Eligibility Criteria
Inclusion
- Male, age 40-80 years.
- Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
- Diagnosis of Dysthymic disorder with onset after age 40.
- PSA \< 4.0.
- Normal digital exam of the prostate in the preceding 1 year.
- 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).
- Able to give informed consent.
Exclusion
- Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
- Currently being treated with testosterone.
- 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.
- Current suicidal risk.
- Current (past year) substance abuse or dependence.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00260390
Start Date
September 1 2004
Last Update
October 4 2006
Active Locations (1)
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1
Sheba Medical Center, Psychiatric out patient clinical unit
Tel Litwinsky, Israel, 52621