A Phase 2 interventional study of Dehydroepiandrosterone in Depressive Disorder and Mood Disorder, sponsored by National Institute of Mental Health (NIMH). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2008-03-04.
Sponsored by National Institute of Mental Health (NIMH) · Phase 2, Interventional, and Treatment
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 effects, including increased heart disease, decreased immune system function, decreased bone density (osteoporosis), high cholesterol, and increased fat to muscle ratio.
Blood levels of DHEA and its sulfate form, DHEA-S, begin dropping when humans are in their 20's. By the time humans are in their 40's and 50's, levels of DHEA and DHEA-S levels are at 50% of their peak. Previous studies have shown that levels of these hormones are associated with feelings of "well-being" and enjoyment of "leisure" activities.
In this study researchers are interested in the effects on mood and behavior of DHEA in men and women with mid-life related mood disorders. Specifically, researchers would like to find out if increasing levels of DHEA will lessen the symptoms associated with these disorders.
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 consequences, including increased cardiovascular disease, decreased immune function, decreased bone density, negative lipid profile and an increased fat to muscle ratio.
In this study, we investigate the effects on mood and behavior of DHEA in men and women with midlife-related mood disorders in a double-blind, placebo-controlled, crossover trial. We specifically ask whether increasing DHEA levels will mitigate any or all of the neurasthenia-like symptoms characteristic of these disorders.
4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.
This study's enrollment of 60 is below the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
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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
The record gives a start of Jun 1995 and a completion of Apr 2004. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2004. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dehydroepiandrosterone
National Institute of Mental Health (NIMH) →