Dehydroepiandrosterone Treatment of Mid-Life-Related Mood Disorders in Women and Men
Dehydroepiandrosterone
Troubles Mentaux
+ Trouble Dépressif
+ Troubles de l'humeur
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1995
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.60 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institute of Mental Health (NIMH)
Bethesda, United StatesOuvrir National Institute of Mental Health (NIMH) dans Google Maps