We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hormonal Levels in Men With Major Depressive Disorder

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429689
First Posted: February 1, 2007
Last Update Posted: August 30, 2011
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.
Information provided by:
Sheba Medical Center
  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

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 2000
  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Amiaz Revital, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00429689     History of Changes
Other Study ID Numbers: SHEBA-06-4480-RA-CTIL
First Submitted: January 31, 2007
First Posted: February 1, 2007
Last Update Posted: August 30, 2011
Last Verified: August 2011

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