Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Key facts

Study ID

NCT07686263

Run by

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

People needed

472

Starts

2026-09-03

Expected to finish

2029-03-03

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
• Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
• Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
• Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
• Item 1 (P1; delusions)
• Item 2 (P2; conceptual disorganization)
• Item 3 (P3; hallucinatory behavior)
• Item 6 (P6; suspiciousness/persecution)
• Participant must have a CGI-S score of ≥ 4 at screening and Day -1
• Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

You may not qualify if…

• Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
• Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
• Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
• Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
• Participant must not have a history of treatment resistance to schizophrenia medications
• Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Local Institution - 0154 — Bentonville, Arkansas, United States
• Local Institution - 0139 — Little Rock, Arkansas, United States
• Local Institution - 0021 — Little Rock, Arkansas, United States
• Local Institution - 0153 — Rogers, Arkansas, United States
• Local Institution - 0190 — Anaheim, California, United States
• Local Institution - 0040 — Bellflower, California, United States
• Local Institution - 0188 — Chino, California, United States
• Local Institution - 0032 — Culver City, California, United States
• Local Institution - 0037 — Garden Grove, California, United States
• Local Institution - 0068 — La Habra, California, United States
• Local Institution - 0128 — Lemon Grove, California, United States
• Local Institution - 0187 — Montclair, California, United States
• Local Institution - 0151 — Orange, California, United States
• Local Institution - 0030 — Pico Rivera, California, United States
• Local Institution - 0185 — Redlands, California, United States
• Local Institution - 0186 — Riverside, California, United States
• Local Institution - 0149 — Hollywood, Florida, United States
• Local Institution - 0145 — Hollywood, Florida, United States
• Local Institution - 0075 — Miami, Florida, United States
• Local Institution - 0054 — Miami Lakes, Florida, United States
• Local Institution - 0134 — Miami Springs, Florida, United States
• Local Institution - 0044 — West Palm Beach, Florida, United States
• Local Institution - 0166 — Atlanta, Georgia, United States
• Local Institution - 0070 — Sandy Springs, Georgia, United States
• Local Institution - 0133 — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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