RecruitingPhase 3NCT07140913

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine


Sponsor

Bristol-Myers Squibb

Enrollment

424 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called Xanomeline/Trospium Chloride for people with bipolar disorder and mania. The study is currently recruiting participants at 103 locations. People eligible for this study include aged 18 Years to 65 Years.

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

DRUGXanomeline/Trospium Chloride

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days


Locations(104)

Pillar Clinical Research - Bentonville

Bentonville, Arkansas, United States

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

Inland Psychiatric Medical Group.

Chino, California, United States

Proscience Research Group

Culver City, California, United States

Omega Clinical Trials - La Habra

La Habra, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

NRC Research Institute

Orange, California, United States

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

South Florida Research Phase I-IV

Miami, Florida, United States

Health Synergy Clinical Research

West Palm Beach, Florida, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Pillar Clinical Research -Chicago

Chicago, Illinois, United States

Arch Clinical Trials

St Louis, Missouri, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Community Clinical Research

Austin, Texas, United States

Elevate Clinical Research-Houston

Houston, Texas, United States

Prime Clinical Research - Mansfield

Mansfield, Texas, United States

Pillar Clinical Research - Richardson

Richardson, Texas, United States

Local Institution - 0011

ABB, Buenos Aires F.D., Argentina

Local Institution - 0010

Córdoba, Argentina

Local Institution - 0012

Córdoba, Argentina

Local Institution - 0008

Córdoba, Argentina

Local Institution - 0009

Mendoza, Argentina

Local Institution - 0114

Santiago del Estero, Argentina

Local Institution - 0184

Kazanlak, Stara Zagora, Bulgaria

State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar

Novi Iskar, Bulgaria

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

Pleven, Bulgaria

Local Institution - 0181

Sliven, Bulgaria

Local Institution - 0086

Targovishte, Bulgaria

Local Institution - 0185

Beijing, Beijing Municipality, China

Local Institution - 0190

Beijing, Beijing Municipality, China

Local Institution - 0191

Guangzhou, Guangdong, China

Local Institution - 0193

Baoding, Hebei, China

Local Institution - 0187

Shijiazhuang, Hebei, China

Local Institution - 0196

Nanjing, Jiangsu, China

Local Institution - 0186

Xi'an, Shaanxi, China

Local Institution - 0192

Chengdu, Sichuan, China

Local Institution - 0188

Tianjin, Tianjin Municipality, China

Local Institution - 0197

Ningbo, Zhejiang, China

Local Institution - 0195

Changsha, China

Local Institution - 0088

Hillerød, Capital Region, Denmark

Local Institution - 0054

Aalborg, North Denmark, Denmark

Local Institution - 0091

Glostrup Municipality, Denmark

Local Institution - 0126

Nice, Alpes-Maritimes, France

Local Institution - 0085

Clermont-Ferrand, Puy-de-Dôme, France

Local Institution - 0087

Marseille, France

Local Institution - 0129

Montpellier, France

Local Institution - 0089

Paris, France

Local Institution - 0121

Mangalore, Karnataka, India

Local Institution - 0123

Madurai, Tamil Nadu, India

Local Institution - 0118

Kolkata, West Bengal, India

Local Institution - 0116

Kolkata, India

Local Institution - 0052

Hod HaSharon, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Local Institution - 0053

Ashkelon, Southern District, Israel

Be'er Sheva Mental Health Center

Beersheba, Southern District, Israel

Local Institution - 0083

Jerusalem, Israel

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Local Institution - 0005

Pisa, Tuscany, Italy

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, Italy

Local Institution - 0004

Ancona, Italy

Local Institution - 0002

Genova, Italy

Okehazama Hospital

Toyoake, Aichi-ken, Japan

Local Institution - 0205

Ichikawa, Chiba, Japan

Local Institution - 0172

Iizuka, Fukuoka, Japan

Local Institution - 0141

Kitakyushu-shi, Fukuoka, Japan

Goryokai Medical Corporation - Goryokai Hospital

Sapporo, Hokkaido, Japan

Local Institution - 0107

Yokohama, Kanagawa, Japan

Rainbow and Sea Hospital

Karatsu, Saga-ken, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Local Institution - 0201

Kodaira, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Kochi Health Sciences Center

Kochi, Japan

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0103

Rybnik, Silesian Voivodeship, Poland

Clinica Inventiva

Tuszyn, Poland

Local Institution - 0093

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"

Bucharest, Romania

Local Institution - 0099

Bucharest, Romania

Local Institution - 0203

Bucharest, Romania

Local Institution - 0097

Iași, Romania

Spitalul de Psihiatrie și Neurologie Brașov

Sanpetru /Brasov, Romania

Local Institution - 0101

Sibiu, Romania

Local Institution - 0167

Smila, Cherkasy Oblast, Ukraine

Local Institution - 0165

Dnipro, Dnipropetrovsk Oblast, Ukraine

Local Institution - 0178

Skarzhyntsi, Khmelnytskyi Oblast, Ukraine

Local Institution - 0163

Nove, Kirovohrad Oblast, Ukraine

Local Institution - 0169

Hlevakha, Kyivska Oblast, Ukraine

Local Institution - 0162

Kyiv, Kyivska Oblast, Ukraine

Local Institution - 0164

Lviv, Lviv Oblast, Ukraine

Local Institution - 0170

Odesa, Odesa Oblast, Ukraine

Local Institution - 0168

Vinnytsia, Vinnytsia Oblast, Ukraine

Local Institution - 0171

Odesa, Ukraine

Local Institution - 0177

Poltava, Ukraine

Local Institution - 0206

Ternopil, Ukraine

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NCT07140913


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