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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

2026-04-01

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 (103)

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

Local Institution - 0160

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

Local Institution - 0124

Novi Iskar, Bulgaria

Local Institution - 0084

Pleven, Bulgaria

Local Institution - 0125

Plovdiv, 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

Local Institution - 0199

Beersheba, Southern District, Israel

Local Institution - 0200

Bnei Brak, Israel

Local Institution - 0083

Jerusalem, Israel

Local Institution - 0003

Milan, Lombardy, Italy

Local Institution - 0005

Pisa, Tuscany, Italy

Local Institution - 0001

Siena, Tuscany, Italy

Local Institution - 0004

Ancona, Italy

Local Institution - 0002

Genova, Italy

Local Institution - 0173

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

Local Institution - 0142

Kochi, Kochi, Japan

Rainbow and Sea Hospital

Karatsu, Saga-ken, Japan

Local Institution - 0180

Bunkyo-ku, Tokyo, Japan

Local Institution - 0139

Bunkyo-ku, Tokyo, Japan

Local Institution - 0201

Kodaira, Tokyo, Japan

Local Institution - 0176

tabashi City, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Local Institution - 0103

Rybnik, Silesian Voivodeship, Poland

Local Institution - 0082

Tuszyn, Łódź Voivodeship, Poland

Local Institution - 0102

Bucharest, București, Romania

Local Institution - 0093

Bucharest, București, Romania

Local Institution - 0098

Bucharest, București, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, Romania

Local Institution - 0096

Bucharest, Romania

Local Institution - 0099

Bucharest, Romania

Local Institution - 0203

Bucharest, Romania

Local Institution - 0097

Iași, Romania

Local Institution - 0095

Sanpetru /Brasov, Romania

Local Institution - 0101

Sibiu, Romania

Local Institution - 0167

Smila, Cherkasy Oblast, Ukraine

Local Institution - 0169

Hlevakha, Kyiv Oblast, Ukraine

Local Institution - 0164

Lviv, Lviv Oblast, Ukraine

Local Institution - 0168

Vinnytsia, Vinnytsia Oblast, Ukraine

Local Institution - 0165

Dnipropetrovsk, Ukraine

Local Institution - 0163

Kropyvnytskyi, Ukraine

Local Institution - 0162

Kyiv, Ukraine

Local Institution - 0170

Odesa, Ukraine

Local Institution - 0171

Odesa, Ukraine

Local Institution - 0177

Poltava, Ukraine

Local Institution - 0178

Skarzhyntsi, Ukraine

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 (103)