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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Dysthymic Disorder
 Drug: Testoviron
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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)

Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00260390

Contacts
Contact: Guy Orr, MD 972-52-6666577 orrg@netvision.net.il

Locations
Israel
Sheba Medical Center, Psychiatric out patient clinical unit Recruiting
Tel Hashomer, Israel, 52621
Contact: Guy Orr, MD     972-52-666577     orrg@netvision.net.il    
Sponsors and Collaborators
Sheba Medical Center
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Guy Orr, MD Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260390     History of Changes
Other Study ID Numbers: SHEBA-04-3222-GO-CTIL
Study First Received: November 30, 2005
Last Updated: October 3, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Dysthymic Disorder
HPG hypofunctioning
Testosterone replacement

Additional relevant MeSH terms:
Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
 Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on May 23, 2013