Hormonal Levels in Men With Major Depressive Disorder

Depression Clinical Trial

Official title:

Hormonal Levels in Men With Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00429689
• Other study ID #: SHEBA-06-4480-RA-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: January 31, 2007
• Last updated: August 28, 2011

Study information

• Verified date: August 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male

• Major Depression Disorder

• 18-65

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Procedure:
• Saliva sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center