RecruitingPhase 3NCT07288567

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 Years of Age)

Sponsor

Bristol-Myers Squibb

Enrollment

166 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT for treatment of Schizophrenia in adolescents.

Eligibility

Min Age: 13 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing KarXT — a new medication that targets different receptors in the brain than most current antipsychotics — for the treatment of schizophrenia in teenagers and young people. **You may be eligible if...** - You are an adolescent with a confirmed diagnosis of schizophrenia (using DSM-5-TR criteria and a structured interview) - You are currently experiencing active psychosis symptoms - Your symptoms are moderately severe or worse at the start of the study (PANSS score of at least 70 and CGI-S of at least 4) **You may NOT be eligible if...** - You have any other primary psychiatric condition besides schizophrenia (within the last 12 months) - You have significant heart, lung, liver, or kidney problems - You have previously had a serious or life-threatening reaction to psychiatric medications - Your symptoms do not meet the severity thresholds at screening or randomization Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

OTHERKarXT Matching Placebo

Specified dose on specified days

Locations(44)

Local Institution - 0077

Anaheim, California, United States

Local Institution - 0058

Chino, California, United States

Local Institution - 0083

Redlands, California, United States

Local Institution - 0089

San Francisco, California, United States

Local Institution - 0032

Orlando, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Local Institution - 0106

Lawrenceville, Georgia, United States

Local Institution - 0039

Stone Mountain, Georgia, United States

EmVenio Research Center - Prime Healthcare

Chicago, Illinois, United States

Local Institution - 0107

Evanston, Illinois, United States

Local Institution - 0076

Boston, Massachusetts, United States

Local Institution - 0100

Brookline, Massachusetts, United States

Local Institution - 0059

Worcester, Massachusetts, United States

Local Institution - 0061

Great Neck, New York, United States

Local Institution - 0051

Cincinnati, Ohio, United States

Local Institution - 0099

Philadelphia, Pennsylvania, United States

Local Institution - 0046

Garland, Texas, United States

Local Institution - 0090

McAllen, Texas, United States

Local Institution - 0066

Spring, Texas, United States

Local Institution - 0050

Richmond, Virginia, United States

Local Institution - 0084

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 0085

La Plata, Buenos Aires, Argentina

Local Institution - 0036

Buenos Aires, Argentina

Local Institution - 0035

Córdoba, Argentina

Local Institution - 0102

Santiago del Estero, Argentina

Local Institution - 0109

Bello, Antioquia, Colombia

Local Institution - 0009

Pereira, Risaralda Department, Colombia

Local Institution - 0001

Barranquilla, Colombia

Local Institution - 0020

Bogotá, Colombia

Local Institution - 0075

Chikugo-Shi, Fukuoka, Japan

Local Institution - 0073

Sapporo, Hokkaido, Japan

Local Institution - 0025

Zentsujichó, Kagawa-ken, Japan

Local Institution - 0062

Miyakonojō, Miyazaki, Japan

Local Institution - 0086

Bunkyo-ku, Tokyo, Japan

Local Institution - 0056

Ōta-ku, Tokyo, Japan

Local Institution - 0063

Yokohama, Kanagawa, Japan

Local Institution - 0029

Bucharest, Bucharest, Romania

Local Institution - 0031

Brasov, Romania

Local Institution - 0040

Bucharest, Romania

Local Institution - 0042

Bucharest, Romania

Local Institution - 0008

Iași, Romania

Local Institution - 0030

Sibiu, Romania

Local Institution - 0005

Timișoara, Romania

Local Institution - 0038

Timișoara, Romania

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NCT07288567

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