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)
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1
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892