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RECRUITING

NCT07140913

PHASE3

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

424

Start Date

2025-10-08

Completion Date

2027-06-28

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Mania Bipolar Disorder

Interventions

DRUG

Xanomeline/Trospium Chloride

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Inclusion Criteria: * Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2. * Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks). * The individual requires hospitalization for the acute exacerbation or relapse of mania. * Body mass index ≥ 18 and ≤ 40 kg/m2. * Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months. * YMRS Total Score of ≥ 18 at Screening and at Baseline, and \< 20% reduction in YMRS from screening to baseline. Exclusion Criteria: * Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders. * Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test. * Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline. * History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months. * History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. * Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results. * Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin \> 1.5× ULN, unless in the context of Gilbert's syndrome. * All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (109)

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

Health Synergy Clinical Research

Boynton Beach, Florida, United States

Local Institution - 0015

Hallandale, Florida, United States

Local Institution - 0021

Miami, Florida, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Pillar Clinical Research -Chicago

Chicago, Illinois, United States

Local Institution - 0209

Indianapolis, Indiana, 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

Adams Clinical Dallas

DeSoto, 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

Clinica El Jardin

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

Beijing Anding Hospital - Affiliated Capital University of Medical Science

Beijing, Beijing Municipality, China

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, China

Guangzhou Brain Hospital

Guangzhou, Guangdong, China

Hebei Mental Health Center

Baoding, Hebei, China

Local Institution - 0187

Shijiazhuang, Hebei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Xi An Mental Health Center

Xi'an, Shaanxi, China

The Fourth People's Hospital of Chengdu

Chengdu, Sichuan, China

Tianjin Anding Hospital

Tianjin, Tianjin Municipality, China

The Affilicated Kangning Hospital of Ningbo University

Ningbo, Zhejiang, China

Local Institution - 0088

Hillerød, Capital Region, Denmark

Aalborg Universitetshospital Psykiatrien

Aalborg, North Denmark, Denmark

Glostrup Hospital

Glostrup Municipality, Denmark

Local Institution - 0126

Nice, Alpes-Maritimes, France

Centre Hospitalier Universitaire de Clermont Ferrand

Clermont-Ferrand, France

Local Institution - 0087

Marseille, France

Local Institution - 0129

Montpellier, France

Local Institution - 0089

Paris, France

Local Institution - 0121

Mangaluru, Karnataka, India

Local Institution - 0123

Madurai, Tamil Nadu, India

Local Institution - 0118

Kolkata, West Bengal, India

Local Institution - 0116

Kolkata, India

Local Institution - 0207

Mangalore, India

Shalvata Mental Health Center

Hod HaSharon, Central District, Israel

Sheba Medical Center

Ramat Gan, Central District, Israel

Barzilai Medical Center

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

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany, Italy

Azienda Ospedaliero Universitaria delle Marche

Ancona, Italy

IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

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

Hino Hospital - Yokohama

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

National Center of Neurology and Psychiatry

Kodaira, Tokyo, Japan

Narimasu Kosei Hospital

tabashi City, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Kochi Health Sciences Center

Kochi, Japan

Wakayama Medical University Hospital

Wakayama, Japan

Instytut Psychiatrii i Neurologii

Warsaw, Masovian Voivodeship, Poland

Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku

Bialystok, Podlaskie 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

Local Institution - 0100

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 - 0097

Iași, Romania

Spitalul de Psihiatrie și Neurologie Brașov

Sanpetru /Brasov, Romania

Local Institution - 0101

Sibiu, Romania

MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC

Dnipro, Dnipropetrovsk Oblast, Ukraine

Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council

Skarzhyntsi, Khmelnytskyi Oblast, Ukraine

Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"

Hlevakha, Kyiv Oblast, Ukraine

And 9 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (109)