A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

PHASE3RecruitingINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

June 11, 2025

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2026

Conditions
Bipolar-I Disorder With Mania or Mania With Mixed Features
Interventions
DRUG

KarXT

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Trial Locations (63)

0

NOT_YET_RECRUITING

Local Institution - 0116, Győr

NOT_YET_RECRUITING

Local Institution - 0114, Budapest

1085

NOT_YET_RECRUITING

Local Institution - 0118, Budapest

1282

NOT_YET_RECRUITING

Local Institution - 0119, Novi Iskar

2065

RECRUITING

Ramsay Clinic Northside, St Leonards

3000

NOT_YET_RECRUITING

Local Institution - 0121, Vratsa

4005

RECRUITING

Ramsay Clinic New Farm, Brisbane

5000

NOT_YET_RECRUITING

Local Institution - 0115, Córdoba

5502

NOT_YET_RECRUITING

Local Institution - 0108, Mendoza

NOT_YET_RECRUITING

Local Institution - 0109, Mendoza

5800

NOT_YET_RECRUITING

Local Institution - 0112, Pleven

8001

NOT_YET_RECRUITING

Local Institution - 0113, Burgas

8800

NOT_YET_RECRUITING

Local Institution - 0120, Sliven

10314

RECRUITING

Richmond Behavioral Associates, Staten Island

30328

RECRUITING

Synexus Clinical Research US, Inc., Atlanta

31405

NOT_YET_RECRUITING

Local Institution - 0057, Savannah

33016

RECRUITING

Innovative Clinical Research, Inc., Miami Lakes

NOT_YET_RECRUITING

Local Institution - 0015, Miami Lakes

33024

RECRUITING

Research Centers of America ( Hollywood ), Hollywood

33033

RECRUITING

Advanced Research Institute of Miami, Homestead

33166

RECRUITING

South Florida Research Phase I-IV, Miami Springs

33426

RECRUITING

Health Synergy Clinical Research, Boynton Beach

44720

RECRUITING

Neuro-Behavioral Clinical Research, North Canton

60641

RECRUITING

Pillar Clinical Research -Chicago, Chicago

72211

RECRUITING

Woodland International Research Group, Little Rock

72712

RECRUITING

Pillar Clinical Research - Bentonville, Bentonville

75062

WITHDRAWN

Local Institution - 0029, Irving

75080

RECRUITING

Pillar Clinical Research - Richardson, Richardson

90703

NOT_YET_RECRUITING

Local Institution - 0014, Cerritos

90706

RECRUITING

CITrials, Bellflower

90806

RECRUITING

Collaborative Neuroscience Research, LLC, Long Beach

91763

RECRUITING

Catalina Research Institute, LLC, Montclair

92805

RECRUITING

Advanced Research Center Inc., Anaheim

92868

RECRUITING

NRC Research Institute, Orange

4838248

NOT_YET_RECRUITING

Local Institution - 0082, Kōnan

06519

NOT_YET_RECRUITING

Local Institution - 0124, New Haven

C1199ABB

NOT_YET_RECRUITING

Local Institution - 0110, ABB

470-1168

RECRUITING

Okehazama Hospital, Toyoake

272-8516

RECRUITING

National Kohnodai Medical Center., Ichikawa

803-0831

WITHDRAWN

Local Institution - 0100, Kitakyushu

080-0024

RECRUITING

Obihiro Kosei Hospital, Obihiro

002-8029

RECRUITING

Goryokai Medical Corporation - Goryokai Hospital, Sapporo

847-0031

RECRUITING

Rainbow and Sea Hospital, Karatsu-shi

350-0495

WITHDRAWN

Local Institution - 0081, Iruma

360-0114

RECRUITING

Saitama Konan Hospital, Kumagaya

187-8551

RECRUITING

National Center of Neurology and Psychiatry, Kodaira

175-0091

RECRUITING

Narimasu Kosei Hospital, tabashi City

819-0037

RECRUITING

Kuramitsu Hospital, Fukuoka

880-8510

NOT_YET_RECRUITING

Local Institution - 0077, Miyazaki

545-8586

RECRUITING

Osaka Metropolitan University Hospital, Osaka

570-8507

NOT_YET_RECRUITING

Local Institution - 0089, Osaka

590-0018

NOT_YET_RECRUITING

Local Institution - 0084, Osaka

157-8577

RECRUITING

Showa Medical University Karasuyama Hospital, Tokyo

641-8510

NOT_YET_RECRUITING

Local Institution - 0076, Wakayama

990-0045

NOT_YET_RECRUITING

Local Institution - 0088, Yamagata

0622

NOT_YET_RECRUITING

Local Institution - 0055, Auckland

61-485

NOT_YET_RECRUITING

Local Institution - 0095, Poznan

02-957

NOT_YET_RECRUITING

Local Institution - 0107, Warsaw

15-272

NOT_YET_RECRUITING

Local Institution - 0094, Bialystok

80-214

NOT_YET_RECRUITING

Local Institution - 0111, Gdansk

44-200

NOT_YET_RECRUITING

Local Institution - 0103, Rybnik

41-200

NOT_YET_RECRUITING

Local Institution - 0102, Sosnowiec

95-080

NOT_YET_RECRUITING

Local Institution - 0096, Tuszyn

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT06951698 - A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder | Biotech Hunter | Biotech Hunter