Completed PHASE3 INTERVENTIONAL 2-arm NCT05919823

A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia (UNITE-001)

A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

Sponsor: Karuna Therapeutics

Conditions Schizophrenia

Interventions Placebo Xanomeline and Trospium Chloride Capsules

Updated 15 times since 2023 Last updated: Dec 1, 2025 Started: May 29, 2023 Primary completion: Sep 16, 2024 Completion: Dec 9, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Schizophrenia, this trial is completed. The trial is conducted by Karuna Therapeutics and has accumulated 15 data snapshots since 2023. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

Change History

15 versions recorded

Jan 2026 — Present [monthly]

Completed PHASE3
Dec 2025 — Jan 2026 [monthly]

Completed PHASE3
May 2025 — Dec 2025 [monthly]

Completed PHASE3

Status: Recruiting → Completed
Dec 2024 — May 2025 [monthly]

Recruiting PHASE3
Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE3

▶ Show 10 earlier versions

Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jun 2024 — Jul 2024 [monthly]

Recruiting PHASE3
May 2024 — Jun 2024 [monthly]

Recruiting PHASE3
Apr 2024 — May 2024 [monthly]

Recruiting PHASE3
Mar 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Nov 2023 — Jan 2024 [monthly]

Recruiting PHASE3
Sep 2023 — Nov 2023 [monthly]

Recruiting PHASE3
Aug 2023 — Sep 2023 [monthly]

Recruiting PHASE3
Jul 2023 — Aug 2023 [monthly]

Recruiting PHASE3

First recorded

May 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Karuna Therapeutics
Zai Lab (Shanghai) Co., Ltd.

Data source: Karuna Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Baoding, China , Beijing, China , Changping, China , Changsha, China , Chengdu, China , Chongqing, China , Daqing, China , Guangyuan, China , Guanzhou, China , Hangzhou, China and 16 more locations