Hormonal Levels in Men With Major Depressive Disorder

NCT ID: NCT00429689

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Saliva sample

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male
* Major Depression Disorder
* 18-65
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Stuart Seidman,, MD

Role: STUDY_DIRECTOR

West End Medical Associates

Revital Amiaz, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Other Identifiers

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SHEBA-06-4480-RA-CTIL

Identifier Type: -

Identifier Source: org_study_id

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