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Trial record 4 of 122 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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE November 30, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date October 4, 2006
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2006)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2005)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Official Title  ICMJE The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
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.

Hypothesis:

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Dysthymic Disorder
Intervention  ICMJE Drug: Testoviron
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00260390
Other Study ID Numbers  ICMJE SHEBA-04-3222-GO-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sheba Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: Guy Orr, MD Sheba Medical Center
PRS Account Sheba Medical Center
Verification Date October 2006

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