Treatment of Mid-Life-Related Mood Disorders

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Nctid: NCT00001487

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003866", "term"=>"Depressive Disorder"}, {"id"=>"D019964", "term"=>"Mood Disorders"}], "ancestors"=>[{"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M7058", "name"=>"Depression", "relevance"=>"LOW"}, {"id"=>"M7061", "name"=>"Depressive Disorder", "asFound"=>"Depressive Disorder", "relevance"=>"HIGH"}, {"id"=>"M21835", "name"=>"Mood Disorders", "asFound"=>"Mood Disorders", "relevance"=>"HIGH"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"T6036", "name"=>"Menopause", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003687", "term"=>"Dehydroepiandrosterone"}], "ancestors"=>[{"id"=>"D000276", "term"=>"Adjuvants, Immunologic"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M6888", "name"=>"Dehydroepiandrosterone", "asFound"=>"Interference", "relevance"=>"HIGH"}, {"id"=>"M3628", "name"=>"Adjuvants, Immunologic", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"T386", "name"=>"DHEA (Dehydroepiandrosterone)", "asFound"=>"Interference", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2004-04", "completionDateStruct"=>{"date"=>"2004-04"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Menopause", "Andropause", "Depression", "DHEA", "Steroids", "Mid-Life Depression", "Mid Life", "Perimenopause", "Climecteric-Related Mood Disorder"], "conditions"=>["Depressive Disorder", "Mood Disorder"]}, "referencesModule"=>{"references"=>[{"pmid"=>"10376113", "type"=>"BACKGROUND", "citation"=>"Bloch M, Schmidt PJ, Danaceau MA, Adams LF, Rubinow DR. Dehydroepiandrosterone treatment of midlife dysthymia. Biol Psychiatry. 1999 Jun 15;45(12):1533-41. doi: 10.1016/s0006-3223(99)00066-9."}, {"pmid"=>"7515387", "type"=>"BACKGROUND", "citation"=>"Morales AJ, Nolan JJ, Nelson JC, Yen SS. Effects of replacement dose of dehydroepiandrosterone in men and women of advancing age. J Clin Endocrinol Metab. 1994 Jun;78(6):1360-7. doi: 10.1210/jcem.78.6.7515387. Erratum In: J Clin Endocrinol Metab 1995 Sep;80(9):2799."}, {"pmid"=>"10942479", "type"=>"BACKGROUND", "citation"=>"Schmidt PJ, Nieman L, Danaceau MA, Tobin MB, Roca CA, Murphy JH, Rubinow DR. Estrogen replacement in perimenopause-related depression: a preliminary report. Am J Obstet Gynecol. 2000 Aug;183(2):414-20. doi: 10.1067/mob.2000.106004."}]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nBlood 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.\n\nIn 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.", "detailedDescription"=>"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.\n\nIn 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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"INCLUSION CRITERIA:\n\nSubjects for this study will meet the following criteria:\n\nA 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;\n\nAge 40-65;\n\nNo prior hormonal therapy for the treatment of menopause/andropause-related mood or physical symptoms within the last six months;\n\nIn good medical health.\n\nEXCLUSION CRITERIA:\n\nThe following conditions will constitute contradictions to treatment with DHEA and will preclude a subject's participation in this protocol:\n\nPositive (threshold) response to SCID major depression section item #9, suicidal ideation;\n\nAnyone requiring immediate treatment after clinical assessment;\n\nSeverity ratings greater than moderate on the SCID;\n\nFunctional impairment ratings of five or six for more than seven consecutive days on daily ratings\n\nCurrent treatment with antidepressant medications\n\nProstate nodules or cancer\n\nModerate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding\n\nHistory of ischemic cardiac disease\n\nRenal disease\n\nHepatic dysfunction\n\nWomen 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\n\nWomen with a history of uterine cancer\n\nPatients with a known hypersensitivity to DHEA or other androgens\n\nPregnant women"}, "identificationModule"=>{"nctId"=>"NCT00001487", "briefTitle"=>"Treatment of Mid-Life-Related Mood Disorders", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Dehydroepiandrosterone Treatment of Mid-Life-Related Mood Disorders in Women and Men", "orgStudyIdInfo"=>{"id"=>"950151"}, "secondaryIdInfos"=>[{"id"=>"95-M-0151"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Dehydroepiandrosterone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Mental Health (NIMH)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Mental Health (NIMH)", "class"=>"NIH"}}}}