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Trial record 4 of 119 for:    Dysthymia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00260390
Recruitment Status : Unknown
Verified October 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : December 1, 2005
Last Update Posted : October 4, 2006
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Sheba Medical Center

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 Testosterone replacement for this condition.


Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.

Condition or disease Intervention/treatment Phase
Dysthymic Disorder Drug: Testoviron Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Study Start Date : September 2004

Primary Outcome Measures :
  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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00260390

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Contact: Guy Orr, MD 972-52-6666577

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Sheba Medical Center, Psychiatric out patient clinical unit Recruiting
Tel Hashomer, Israel, 52621
Contact: Guy Orr, MD    972-52-666577   
Sponsors and Collaborators
Sheba Medical Center
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: Guy Orr, MD Sheba Medical Center
Layout table for additonal information Identifier: NCT00260390    
Other Study ID Numbers: SHEBA-04-3222-GO-CTIL
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: October 4, 2006
Last Verified: October 2006
Keywords provided by Sheba Medical Center:
Dysthymic Disorder
HPG hypofunctioning
Testosterone replacement
Additional relevant MeSH terms:
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Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs