[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589691":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":26,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Federal University of São Paulo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine","EXPERIMENTAL","Participants were randomly by assigned. ketamine will be used as an adjunctive treatment at an initial dose of 0.5 mg\u002Fkg, administered subcutaneously twice weekly for four weeks under double-blind conditions. Dose adjustments between 0.5 to 1.0 mg\u002Fkg may occur based on patient response and tolerability.",[13],"Drug: ketamine",{"label":15,"type":16,"description":17,"interventionNames":18},"Midazolam","PLACEBO_COMPARATOR","For the placebo group, midazolam will be administered subcutaneously at a dose of 1 mg diluted in 5 ml of 0.9% saline, twice weekly for four consecutive weeks, also under double-blind conditions.",[19],"Drug: Midazolam",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ketamine","Ketamine will be administered as adjunctive therapy at an initial dose of 0.5 mg\u002Fkg via subcutaneous injection, twice weekly for four weeks, under double-blind conditions. Dose adjustments between 0.5 and 1.0 mg\u002Fkg will be based on depressive symptoms, efficacy, and tolerability. All procedures will occur at the Ketamine Clinic of Federal University of São Paulo.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Midazolam will be administered subcutaneously twice weekly for four consecutive weeks, also under double-blind conditions. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Sheila C Caetano, Phd","CONTACT","551197824398","sheila.caetano@unifesp.br",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Sheila Cavalcante Caetano","Professor; Post doctor","100589691","phase-3-evaluation-of-the-efficacy-and-safety-of-subcutaneous-ketamine-in-the-treatment-of-depressive-episode-with-suicidal-ideation-andor-behavior-in-adolescents-100589691",false,"NCT06957704","Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and\u002For Behavior in Adolescents","Inclusion Criteria:\n\n* Age between 12 and 19 years.\n* Diagnosis of Major Depressive Episode, unipolar, made through the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL) administered by experienced evaluators, using DSM-5 criteria.\n* Under usual treatment for Major Depressive Episode, including clinically indicated psychopharmacological treatment and\u002For psychosocial treatment at one of the two collaborating clinics (DICA and Conversas de Vida \u002F Unifesp).\n* Score ≥ 25 on the MADRS (Montgomery-Åsberg Depression Rating Scale).\n* Score ≥ 28 on the CDRS (Children Depression Rating Scale).\n* Score ≥ 2 on the Columbia Suicide Severity Rating Scale (C-SSRS).\n* History of suicide attempt or significant suicidal ideation or planning with a plan or intention requiring emergency evaluation in the last 30 days.\n\nExclusion Criteria:\n\n* Presence of the following psychiatric comorbidities: Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or psychiatric disorder secondary to physical illness, and history of ketamine or other substance abuse or dependence in the last 6 months.\n* Presence of Intellectual Disability (assessed by IQ testing).\n* Presence of the following clinical comorbidities: history of myocardial infarction, congenital heart disease, decompensated cardiac arrhythmia, decompensated hypertension, porphyria, stroke, brain trauma with loss of consciousness, intracranial hypertension, hydrocephalus, central nervous system tumors, or central nervous system abnormalities.\n* Previous treatment for depression with esketamine.\n* Allergy to esketamine.\n* If female: pregnancy or breastfeeding.","ALL","12 Years","19 Years",{"count":50,"type":51},60,"ESTIMATED","INTERVENTIONAL",[54],"PHASE3","Evaluate the efficacy and safety of subcutaneous ketamine added to usual treatment in the management of depressive episodes with suicidal ideation or behavior in adolescent patients, compared to usual treatment added to placebo (midazolam).",[57,58],"Depressive Disorder","Suicidal Ideas",[60,9,61,15],"Adolescent","Major Depressive Disorder","NOT_YET_RECRUITING","2025-05-02",{"date":65,"type":66},"2025-05-04","ACTUAL",{"date":68,"type":51},"2025-05",{"date":70,"type":51},"2028-04",{"name":5,"class":6}]