{"id":"nct:NCT05145413","kind":"trial","title":"A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia","authors":["Karuna Therapeutics, Inc., a Bristol Myers Squibb company"],"author_count":1,"year":2021,"published":"2021-12-06","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT05145413","source_url":"https://clinicaltrials.gov/study/NCT05145413","archive_url":"https://space-kitty.com/papers/nct:NCT05145413","updated":"2026-05-05","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \\[BID\\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.","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,"retracted":false,"peer_reviewed":null,"categories":["Schizophrenia"],"details":{"acronym":"ARISE","status":"COMPLETED","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":396,"sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","conditions":["Schizophrenia"],"interventions":["DRUG: Xanomeline and Trospium Chloride Capsules","DRUG: Placebo"],"start_date":"2021-11-12","start_date_type":"ACTUAL","primary_completion_date":"2025-03-19","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":[]}