Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dysthymic Disorder
Intervention: Testoviron (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Guy Orr, MD, Principal Investigator, Affiliation: Sheba Medical Center
Overall contact:
Guy Orr, MD, Phone: 972-52-6666577, Email: orrg@netvision.net.il
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.
Clinical Details
Official title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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)
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Male.
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.
Locations and Contacts
Guy Orr, MD, Phone: 972-52-6666577, Email: orrg@netvision.net.il
Sheba Medical Center, Psychiatric out patient clinical unit, Tel Hashomer 52621, Israel; Recruiting
Guy Orr, MD, Phone: 972-52-666577, Email: orrg@netvision.net.il
Additional Information
Starting date: September 2004
Last updated: October 3, 2006
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