Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
NCT ID: NCT00260390
Last Updated: 2006-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
INTERVENTIONAL
2004-09-30
Brief Summary
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Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Testoviron
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
MALE
No
Sponsors
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National Alliance for Research on Schizophrenia and Depression
OTHER
Sheba Medical Center
OTHER_GOV
Principal Investigators
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Guy Orr, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center, Psychiatric out patient clinical unit
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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Guy Orr, MD
Role: primary
Other Identifiers
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SHEBA-04-3222-GO-CTIL
Identifier Type: -
Identifier Source: org_study_id