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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00260390
First received: November 30, 2005
Last updated: October 3, 2006
Last verified: October 2006

November 30, 2005
October 3, 2006
September 2004
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  • 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)
  • 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)
Complete list of historical versions of study NCT00260390 on ClinicalTrials.gov Archive Site
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Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Dysthymic Disorder
Drug: Testoviron
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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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.
Male
40 Years to 80 Years
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Contact: Guy Orr, MD 972-52-6666577 orrg@netvision.net.il
Israel
 
NCT00260390
SHEBA-04-3222-GO-CTIL
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Sheba Medical Center
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Guy Orr, MD Sheba Medical Center
Sheba Medical Center
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP