NCT07686263From ClinicalTrials.govRecruiting

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

Schizophrenia

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrolment target: 472
Started: 20 August 2026
Main results due: 3 March 2029
Study sites: 59
Registry updated: 28 September 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria

* 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:

1. Item 1 (P1; delusions)
2. Item 2 (P2; conceptual disorganization)
3. Item 3 (P3; hallucinatory behavior)
4. 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.

Exclusion Criteria

* 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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(59)

Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States
Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Recruiting
Local Institution - 0021
Little Rock, Arkansas, United States
Not yet recruiting
Local Institution - 0153
Rogers, Arkansas, United States
Not yet recruiting
Local Institution - 0190
Anaheim, California, United States
Not yet recruiting
Local Institution - 0040
Bellflower, California, United States
Not yet recruiting
Local Institution - 0188
Chino, California, United States
Not yet recruiting
Local Institution - 0032
Culver City, California, United States
Not yet recruiting
Local Institution - 0037
Garden Grove, California, United States
Not yet recruiting
Local Institution - 0068
La Habra, California, United States
Not yet recruiting
Local Institution - 0128
Lemon Grove, California, United States
Not yet recruiting
Local Institution - 0187
Montclair, California, United States
Not yet recruiting
Local Institution - 0151
Orange, California, United States
Not yet recruiting
Local Institution - 0030
Pico Rivera, California, United States
Not yet recruiting
Local Institution - 0185
Redlands, California, United States
Not yet recruiting
Local Institution - 0186
Riverside, California, United States
Not yet recruiting
Local Institution - 0193
Torrance, California, United States
Not yet recruiting
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Recruiting
Local Institution - 0075
Miami, Florida, United States
Withdrawn
Local Institution - 0054
Miami Lakes, Florida, United States
Withdrawn
Local Institution - 0134
Miami Springs, Florida, United States
Withdrawn
Local Institution - 0195
Oakland Park, Florida, United States
Not yet recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Recruiting
Local Institution - 0070
Sandy Springs, Georgia, United States
Not yet recruiting
Local Institution - 0189
Savannah, Georgia, United States
Not yet recruiting
Local Institution - 0067
Chicago, Illinois, United States
Not yet recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, United States
Recruiting
Local Institution - 0192
Gaithersburg, Maryland, United States
Not yet recruiting
Local Institution - 0183
Cincinnati, Ohio, United States
Not yet recruiting
Local Institution - 0047
Oklahoma City, Oklahoma, United States
Not yet recruiting
Local Institution - 0049
Austin, Texas, United States
Not yet recruiting
Local Institution - 0194
Dallas, Texas, United States
Not yet recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Recruiting
Local Institution - 0175
Río Cuarto, Córdoba Province, Argentina
Withdrawn
Local Institution - 0143
Buenos Aires, Argentina
Withdrawn
Local Institution - 0002
Córdoba, Argentina
Not yet recruiting
Local Institution - 0144
Santiago del Estero, Argentina
Not yet recruiting
Local Institution - 0191
Novi Iskar, Bulgaria
Not yet recruiting
Local Institution - 0162
Brno, Czechia
Not yet recruiting
Local Institution - 0014
Klecany, Czechia
Not yet recruiting
Local Institution - 0159
Aarhus, Central Jutland, Denmark
Not yet recruiting
Local Institution - 0182
Hovedvejen 19, Frederiksberg, Denmark
Not yet recruiting
Local Institution - 0157
Glostrup, Region Sjælland, Denmark
Not yet recruiting
Local Institution - 0158
Aalborg, Denmark
Not yet recruiting
Local Institution - 0123
Warsaw, Masovian Voivodeship, Poland
Not yet recruiting
Local Institution - 0122
Bialystok, Podlaskie Voivodeship, Poland
Not yet recruiting
Local Institution - 0001
Poznan, Poland
Not yet recruiting
Local Institution - 0103
Bucharest, Bucharest, Romania
Not yet recruiting
Local Institution - 0105
Bucharest, Bucharest, Romania
Not yet recruiting
Local Institution - 0107
Bucharest, Bucharest, Romania
Not yet recruiting
Local Institution - 0110
Bucharest, Bucharest, Romania
Not yet recruiting
Local Institution - 0174
Bucharest, Romania
Not yet recruiting
Local Institution - 0106
Bucharest, Romania
Not yet recruiting
Local Institution - 0109
Bucharest, Romania
Not yet recruiting
Local Institution - 0112
Barcelona, Barcelona [Barcelona], Spain
Not yet recruiting
Local Institution - 0167
Valladolid, Spain
Not yet recruiting
Local Institution - 0181
Zamora, Spain
Not yet recruiting
Local Institution - 0094
Cambridge, United Kingdom
Not yet recruiting

Showing 59 of 59 sites. 7 of the 59 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07686263. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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