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Hormonal Levels in Men With Major Depressive Disorder

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00429689
First received: January 31, 2007
Last updated: August 28, 2011
Last verified: August 2011
History of Changes
  Purpose

Subjects will be 1000 men meeting the following inclusion criteria: 1) male, age 18-65 years; 2) meeting DSM-IV criteria for major depressive disorder within the past one year, with a HAM-D score >12.

Subjects will be excluded if they exhibit 1) a substance abuse or dependence disorder within the past year; 2) current psychotic symptoms; or 3) a history of bipolar disorder.

Procedure

After informed consent, eligible patients will have blood drawn for serum hormone levels; cortisol, DHEA-S and testosterone or they will provide a salivary sample for measurement of hormone levels.

We will also test hormone level form 1000 healthy males (from blood or saliva) at the same age for comparison.


Condition Intervention
Depression
 Procedure: Saliva sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hormonal Levels in Men With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 2000
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men diagnosed with Major depression disorder

Criteria

Inclusion Criteria:

  • Male
  • Major Depression Disorder
  • 18-65
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429689

Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Stuart Seidman,, MD West End Medical Associates
Principal Investigator: Revital Amiaz, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Amiaz Revital, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00429689     History of Changes
Other Study ID Numbers: SHEBA-06-4480-RA-CTIL
Study First Received: January 31, 2007
Last Updated: August 28, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Sheba Medical Center:
Male, MDD, Testosterone, DHEA-S,Cortisol
Male
18-65
Major Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013