[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657954":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":55,"studyPopulation":55,"armGroups":64,"interventions":77,"overallOfficials":86,"centralContacts":91,"locations":99,"responsibleParty":200,"collaborators":55,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":206,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":55,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":224,"overallStatus":102,"whyStopped":55,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change score in MADRS (Montgomery-Asberg-Depression Rating Scale)","The MADRS is a rating scale to measure depression severity. Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.","6 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"MADRS response and remission","MADRS response (defined as 50 % MADRS score reduction)\n\nMADRS remission (defined as MADRS score \\\u003C 10)",{"measure":18,"description":19,"timeFrame":12},"Adverse event-related treatment discontinuation","Number and proportion of participants who discontinue study treatment due to an adverse event. Unit of Measure: Number and percentage of participants",[21,24,27,30,33,36,40,43,46,49],{"measure":22,"description":23,"timeFrame":12},"Immunometabolic Changes","Change from baseline to Week 6 in C-reactive protein (CRP) concentration. Unit of Measure: mg\u002FL",{"measure":25,"description":26,"timeFrame":12},"Immunometabolic Changes (2)","Change from baseline to Week 6 in interleukin-6 (IL-6) concentration. Unit of Measure: pg\u002FmL",{"measure":28,"description":29,"timeFrame":12},"Number and proportion of participants experiencing adverse events","AEs) and serious adverse events (SAEs) during the 6-week treatment period. Unit of Measure: Number and percentage of participants",{"measure":31,"description":32,"timeFrame":12},"Quality of life assessed with EQ-5D-3L","Change from baseline to Week 6 in health-related quality of life as assessed using the EQ-5D-3L. The EQ-5D-3L index value will be derived according to the prespecified scoring algorithm.",{"measure":34,"description":35,"timeFrame":12},"Clinical improvement assessed with CGI-I","Clinical improvement at Week 6 as assessed using the Clinical Global Impression-Improvement (CGI-I) scale.\n\nUnit of Measure: CGI-I score",{"measure":37,"description":38,"timeFrame":39},"Treatment acceptability: All-cause dropout","Number and proportion of participants who discontinue the study for any reason during the 6-week study period.\n\nUnit of Measure: Number and percentage of participants","Time Frame: 6 weeks",{"measure":41,"description":42,"timeFrame":12},"Medication adherence assessed with MARS-5","Medication adherence at Week 6 as assessed using the 5-item Medication Adherence Rating Scale (MARS-5). Item scores are summed to obtain the total MARS-5 score. Unit of Measure: MARS-5 total score",{"measure":44,"description":45,"timeFrame":12},"Clinical severity assessed with CGI-S","Clinical severity at Week 6 as assessed using the Clinical Global Impression-Severity (CGI-S) scale.\n\nUnit of Measure: CGI-S score",{"measure":47,"description":48,"timeFrame":12},"Social functioning assessed with SOFAS","Change from baseline to Week 6 in social and occupational functioning as assessed using the Social and Occupational Functioning Assessment Scale (SOFAS).\n\nUnit of Measure: SOFAS score",{"measure":50,"description":51,"timeFrame":12},"Patient-rated improvement assessed with PGIC","Patient-rated overall change at Week 6 as assessed using the Patient Global Impression of Change (PGIC).\n\nUnit of Measure: PGIC score",{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":55,"timePerspective":55,"maskingInfo":57},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":58,"maskingDescription":55,"whoMasked":59},"QUADRUPLE",[60,61,62,63],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"DHEA","EXPERIMENTAL","100 mg\u002Fd DHEA to continued standard antidepressant medication",[70],"Drug: Dehydroepiandrosterone (DHEA)",{"label":72,"type":73,"description":74,"interventionNames":75},"Placebo","PLACEBO_COMPARATOR","Placebo to continued standard antidepressant medication",[76],"Drug: Placebo",[78,83],{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":55},"DRUG","Dehydroepiandrosterone (DHEA)","Dehydroepiandrosterone (DHEA) will be administered orally at a fixed dose of 100 mg\u002Fday for 6 weeks as add-on treatment to continued standard antidepressant monotherapy. Standard antidepressant medication will be continued at an unchanged dose throughout the treatment period.",[66],{"type":79,"name":72,"description":84,"armGroupLabels":85,"otherNames":55},"Matching placebo capsules, indistinguishable from the investigational product, will be administered orally for 6 weeks as add-on treatment to continued standard antidepressant monotherapy.",[72],[87],{"name":88,"affiliation":89,"role":90},"Christian Otte, MD","Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie, Berlin, Berlin 12203","STUDY_DIRECTOR",[92,96],{"name":88,"role":93,"phone":94,"phoneExt":55,"email":95},"CONTACT","0049 30 450 617615","christian.otte@charite.de",{"name":97,"role":93,"phone":55,"phoneExt":55,"email":98},"Deniz Yildirim Dogan, MD","Deniz-Yildirim.Dogan@charite.de",[100,114,125,134,145,156,167,178,189],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":55},"Charité - Universitätsmedizin Berlin, Klinik für Psychiatrie und Psychotherapie","RECRUITING","Berlin","State of Berlin","12203","Germany","DE",{"type":109,"coordinates":110},"Point",[111,112],13.41053,52.52437,{"lat":112,"lon":111},{"facility":115,"status":102,"city":116,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Klinik für Psychiatrie, Psychotherapie und Psychosomatik der Universität Augsburg","Augsburg",{"type":109,"coordinates":118},[119,120],10.89851,48.37154,{"lat":120,"lon":119},[123],{"name":124,"role":93,"phone":55,"phoneExt":55,"email":55},"Alkomiet Hasan, MD",{"facility":126,"status":102,"city":103,"state":55,"zip":127,"country":106,"countryCode":107,"cosmosGeoPoint":128,"geoPoint":130,"contacts":131},"Alexianer St. Hedwig Krankenhaus, Berlin","10115",{"type":109,"coordinates":129},[111,112],{"lat":112,"lon":111},[132],{"name":133,"role":93,"phone":55,"phoneExt":55,"email":55},"Nicola Schoofs, MD",{"facility":135,"status":102,"city":136,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Universitätsklinikum Frankfurt, Klinik für Psychiatrie, Psychosomatik und Psychotherapie,","Frankfurt",{"type":109,"coordinates":138},[139,140],10.53333,49.68333,{"lat":140,"lon":139},[143],{"name":144,"role":93,"phone":55,"phoneExt":55,"email":55},"Andreas Reif, MD",{"facility":146,"status":102,"city":147,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Klinik für Psychiatrie und Psychotherapie am Universitätsklinikum Freiburg","Freiburg im Breisgau",{"type":109,"coordinates":149},[150,151],7.85222,47.9959,{"lat":151,"lon":150},[154],{"name":155,"role":93,"phone":55,"phoneExt":55,"email":55},"Katharina Domschke, MD",{"facility":157,"status":102,"city":158,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Psychiatrie und Psychotherapie","Hamburg",{"type":109,"coordinates":160},[161,162],9.99302,53.55073,{"lat":162,"lon":161},[165],{"name":166,"role":93,"phone":55,"phoneExt":55,"email":55},"Gregor Leicht, MD",{"facility":168,"status":102,"city":169,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Universitätsklinikum Leipzig, Klinik und Poliklinik für Psychiatrie und Psychotherapie","Leipzig",{"type":109,"coordinates":171},[172,173],12.37129,51.33962,{"lat":173,"lon":172},[176],{"name":177,"role":93,"phone":55,"phoneExt":55,"email":55},"Maria Strauß, MD",{"facility":179,"status":102,"city":180,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Klinik für Psychiatrie und Psychotherapie am LMU Klinikum","München",{"type":109,"coordinates":182},[183,184],13.31243,51.60698,{"lat":184,"lon":183},[187],{"name":188,"role":93,"phone":55,"phoneExt":55,"email":55},"Conelius Schüle, MD",{"facility":190,"status":102,"city":191,"state":55,"zip":55,"country":106,"countryCode":107,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Helios Hanseklinikum Stralsund Klinik und Poliklinik für Psychiatrie","Stralsund",{"type":109,"coordinates":193},[194,195],13.0818,54.30911,{"lat":195,"lon":194},[198],{"name":199,"role":93,"phone":55,"phoneExt":55,"email":55},"Deborah Janowitz",{"type":201,"investigatorFullName":202,"investigatorTitle":203,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"PRINCIPAL_INVESTIGATOR","Prof. Dr. Christian Otte","Professor of Psychiatry","100657954","phase-3-dehydroepiandrosterone-dhea-as-augmentation-of-standard-antidepressants-in-treatment-resistant-depression-100657954",false,"NCT07843927","Dehydroepiandrosterone (DHEA) as Augmentation of Standard Antidepressants in Treatment-resistant Depression.","Dehydroepiandrosterone (DHEA) as Augmentation of Standard An-tidepressants in Treatment-resistant Depression: a Randomized Controlled Trial (DARE-Trial) - A Multicenter, Randomized, Double-blind, Placebo-controlled Trial With Group Sequential Design","DARE","Inclusion Criteria:\n\n* Patient provided written informed consent\n\n  -,The patient is capable of giving consent (has sufficient knowledge of German and clearly understands the nature, significance and scope, including risks, of the medical procedure)\n* The patients is aged between 18 and 75 years (≥ 18 and ≤ 75)\n* The patient has an episode of major depression according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edi-tion)\n* The patient has treatment-resistant depression (TRD), defined as non-response to at least one 4-week antidepressant treatment trial (including the current treatment) in the index episode (correspond-ing to level 1 resistance to treatment failure according to the Maudsley staging method)\n* The patient has a Montgomery-Asberg Depression Rating Scale (MADRS) score of ≥ 20\n* The patient is receiving antidepressant medication (SSRI or SNRI or tricyclic antidepressant or mirtazapine or bupropion) for at least 4 weeks, the dosage is at least at the approved minimum thera-peutic dosage and has been unchanged for at least 14 days prior to screening visit.\n* The patient had less than three (\\\u003C3) treatment attempts with anti-depressants in the current MDE (current treatment attempts not in-cluded).\n\nExclusion Criteria:\n\n* Exclusion Criteria Related to psychiatric diagnosis\n* The patient has current clinically significant suicidal ideation with intent, corresponding to a score of 4 or 5 for ideation on the C-SSRS, or a suicidal attempt within the past 6 months, as indicated by the C-SSRS at screening visit\n* The patient fulfills the criteria for psychotic depression according to DSM-5\n* The patient meets the criteria for schizophrenia, schizoaffective disorder or bipolar disorder in M.I.N.I according to DSM-5\n* The patient meets the criteria for a dependency disorder in the M.I.N.I. for DSM-5\n* The patient has dementia or moderate to severe cognitive impair-ment. Exclusion Criteria Related to IMP\n* The Patient is currently taking DHEA or has taken it within the last 14 days prior to screening visit.\n* The patients is currently taking hormone replacement therapy with sex hormones (other than contraceptives)\n* The patient has undiagnosed genital bleeding\n* The patient has untreated endometrial hyperplasia The patient has or has had sex hormone-dependent cancer (e.g. breast cancer, ovarian cancer, endometrial cancer, prostate can-cer)\n* The patient is allergic or has contraindication to DHEA or lactulose and cellulose\n* The patient has previous diagnosis of chronic kidney disease stage G3b (or higher) or GFR \\\u003C 30 ml\u002Fmin.\n* The patient has diagnosis of prostatic hyperplasia. Exclusion Criteria Related to standard antidepressant medication (AxMP)\n* The Patient is taking antidepressants other than those listed as in-clusion criterion (SSRI, SNRI, tricyclic antidepressants, bupropion, mirtazapine)\n* The patient is taking psychotropic medication, e.g. antipsychotics, anticonvulsants, lithium or Johannis herbs. Allowed substances in-clude benzodiazepines, non-benzodiazepines (Zopiclon, Zolpidem or Eszopiclon) and antidepressants listed under inclusion criteria.\n* The patient is using non-selective, irreversible MAO inhibitors (e.g. tranylcypromine) or selective, reversible MAO-A inhibitors (e.g. moclobemide) or the reversible non-selective MAO inhibitor line-zolid\n* The patient has insulin-dependent diabetes mellitus General Safety Exclusion Criteria\n* The patient has an untreated and unstable general medical condi-tion (e.g. hypertension with end organ damage or hypertensive de-railment)\n* The patient has a medical history of liver failure and\u002For bilirubin above 3 times the normal range and reduced total protein\n* The patient is pregnant or breastfeeding.\n* The patient of childbearing age shows an unwillingness to use an effective contraceptive method (defined as a Pearl Index \\\u003C 1)\n* The patient currently has or has a history of venous thromboembo-lism (VTE) (deep vein thrombosis, pulmonary embolism)\n* The patient currently has or has a history of arterial thromboem-bolic disease (e.g. angina pectoris, myocardial infarction, stroke)\n* The patient has a thrombophilic disease (e.g. protein C, protein S or antithrombin deficiency)\n* The patient has porphyria\n* The patient has clinically significant untreated hypothyroidism\n* The patient has clinically significant abnormalities in the 12-lead ECG (e.g. prolongation of the QTc interval ≥ 500 ms) as performed during screening visit\n* The patient is a vulnerable person (defined as: persons deprived their liberty, confined to an institution by court or administrative or-der, persons that may have Insufficient power, intelligence, educa-tion, resources, strength, or other needed attributes to protect their own interests, or unable to explicitly give consent)\n* The patient might be dependent on representative of the sponsor, the investigator or the trial site The patient is currently participating in another interventional clini-cal trial.\n\nLaboratory Exclusion Criteria\n\n* The patient's laboratory values show clinically significant abnor-malities\n* The patient currently has liver disease with liver-specific levels out-side the age- and gender-specific reference intervals \\[elevations of GOT or GPT above 3 times the upper normal value (ULN)\\]","ALL","18 Years","75 Years",{"count":216,"type":217},320,"ESTIMATED","INTERVENTIONAL",[220],"PHASE3","Major depressive disorder (MDD) is a major contributor to impaired health worldwide. Initial antidepressant treatment of MDD does not lead to response in up to 50 % of patients. TRD (Treatment Resistant Depression) is associated with increased rates of recurrence, mortality as well as increased treating costs compared to MDD. Treatment op-tions for TRD remain limited with lithium, quetiapine and esketamine being the only recommended and approved augmentation strategies in the EU. Dehydroepiandrosterone (DHEA), an endogenous steroid hormone, is a promising, safe and tolerable adjunctive treatment op-tion. DHEA has been meta-analytically shown to elicit antidepressant effects and to be safe both in MDD and for depressive symptoms in other medical diseases. However, previous RCTs (Randomized con-trolled trial) were small and no study has yet tested the antidepressant potential of adjunct treatment with DHEA in patients with TRD.\n\nPrimary objective To determine whether add-on 100 mg\u002Fd DHEA to continued standard antidepressant medication improves depression to a greater extent than add-on placebo in subjects with treatment-resistant depression.\n\nSecondary objectives To determine whether add-on 100 mg\u002Fd DHEA to continued standard antidepressant medication improves response rates, remission rates, patients' impression of change, clinician's impression of severity and change, quality of life, social functioning and self-report depression se-verity to a greater extent than adjunct placebo in subjects with TRD. Furthermore, changes in glucose, glycosylated hemoglobin (HbA1c), total, HDL- and LDL-cholesterol, C-reactive protein (CRP), and inter-leukin-6 levels from baseline to week 6 will be determined.",[223],"Treatment Resistant Depression (TRD)",[225,66,226],"TRD","MDD","2026-09-21",{"date":229,"type":230},"2026-09-28","ACTUAL",{"date":232,"type":230},"2026-06-22",{"date":234,"type":217},"2028-09-30",{"name":5,"class":6},9]