Status:

COMPLETED

Treatment of Mid-Life-Related Mood Disorders

Lead Sponsor:

National Institute of Mental Health (NIMH)

Conditions:

Depressive Disorder

Mood Disorder

Eligibility:

All Genders

Phase:

PHASE2

Brief Summary

Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland. As humans grow older the levels of DHEA naturally decrease. Low levels of DHEA have been associated with a variety of harmful ...

Detailed Description

Dehydroepiandrosterone (DHEA) is a hormone produced by the adrenal gland in concentrations that decrease with age. In humans low DHEA levels have been associated with a variety of adverse biological c...

Eligibility Criteria

INCLUSION CRITERIA:

Subjects for this study will meet the following criteria:

A current episode of minor (meeting 3-4 criterion symptoms) or major depression of moderate severity or less on the SCID severity scale for depression and not meeting DSM-IV criteria symptom #9 (suicide) as determined by the administration of the minor depression module of the SADS-L and the Structured Clinical Interview for DSM-IV. Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria #9 (suicide), or anyone requiring immediate treatment after clinical assessment, functional impairment ratings of five or six for more than seven consecutive days on daily ratings;

Age 40-65;

No prior hormonal therapy for the treatment of menopause/andropause-related mood or physical symptoms within the last six months;

In good medical health.

EXCLUSION CRITERIA:

The following conditions will constitute contradictions to treatment with DHEA and will preclude a subject's participation in this protocol:

Positive (threshold) response to SCID major depression section item #9, suicidal ideation;

Anyone requiring immediate treatment after clinical assessment;

Severity ratings greater than moderate on the SCID;

Functional impairment ratings of five or six for more than seven consecutive days on daily ratings

Current treatment with antidepressant medications

Prostate nodules or cancer

Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding

History of ischemic cardiac disease

Renal disease

Hepatic dysfunction

Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer

Women with a history of uterine cancer

Patients with a known hypersensitivity to DHEA or other androgens

Pregnant women

Key Trial Info

Start Date :

June 1 1995

Trial Type :

INTERVENTIONAL

End Date :

April 1 2004

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00001487

Start Date

June 1 1995

End Date

April 1 2004

Last Update

March 4 2008

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

National Institute of Mental Health (NIMH)

Bethesda, Maryland, United States, 20892

Treatment of Mid-Life-Related Mood Disorders | DecenTrialz