Treatment of Mid-Life-Related Mood Disorders

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001487
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: April 2004
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Mood Disorder
Drug: Dehydroepiandrosterone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Dehydroepiandrosterone Treatment of Mid-Life-Related Mood Disorders in Women and Men

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 60
Study Start Date: June 1995
Estimated Study Completion Date: April 2004
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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001487

Locations
United States, Maryland
National Institute of Mental Health (NIMH)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001487     History of Changes
Other Study ID Numbers: 950151, 95-M-0151
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Menopause
Andropause
Depression
DHEA
Steroids
Mid-Life Depression
Mid Life
Perimenopause
Climecteric-Related Mood Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014