{"id":"nct:NCT02417064","kind":"trial","title":"A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression","authors":["Janssen Research & Development, LLC"],"author_count":1,"year":2015,"published":"2015-04-15","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT02417064","source_url":"https://clinicaltrials.gov/study/NCT02417064","archive_url":"https://space-kitty.com/papers/nct:NCT02417064","updated":"2025-04-29","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"peer_reviewed":null,"categories":["Treatment-resistant Depression"],"details":{"acronym":"TRANSFORM-1","status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":346,"sponsor":"Janssen Research & Development, LLC","conditions":["Treatment-resistant Depression"],"interventions":["DRUG: Esketamine","DRUG: Placebo","DRUG: Duloxetine (Oral Antidepressant)","DRUG: Escitalopram (Oral antidepressant)","DRUG: Sertraline (Oral Antidepressant)","DRUG: Venlafaxine Extended Release (XR) (Oral Antidepressant)"],"start_date":"2015-08-10","start_date_type":"ACTUAL","primary_completion_date":"2018-02-20","has_results":true,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"psychiatric-therapeutics","name":"Novel Psychiatric Therapeutics","domain_slug":"neuroscience"}],"cited_in_dossiers":[]}