A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

June 13, 2028

Study Completion Date

June 13, 2028

Conditions
Bipolar Disorder Type I With Mania
Interventions
DRUG

KarXT

Specified dose on specified days

DRUG

Lithium

Therapeutic dose

DRUG

Valproate

Therapeutic dose

DRUG

Lamotrigine

Therapeutic dose

Trial Locations (141)

0

NOT_YET_RECRUITING

Local Institution - 0109, Győr

NOT_YET_RECRUITING

Local Institution - 0110, Budapest

NOT_YET_RECRUITING

Local Institution - 0094, Bucharest

1085

NOT_YET_RECRUITING

Local Institution - 0108, Budapest

1282

NOT_YET_RECRUITING

Local Institution - 0107, Novi Iskar

2065

RECRUITING

Ramsay Clinic Northside, St Leonards

3000

NOT_YET_RECRUITING

Local Institution - 0114, Vratsa

4005

RECRUITING

Ramsay Clinic New Farm, Brisbane

5000

NOT_YET_RECRUITING

Local Institution - 0127, Córdoba

5502

NOT_YET_RECRUITING

Local Institution - 0126, Mendoza

5800

NOT_YET_RECRUITING

Local Institution - 0081, Pleven

8001

NOT_YET_RECRUITING

Local Institution - 0082, Burgas

8800

NOT_YET_RECRUITING

Local Institution - 0113, Sliven

10090

WITHDRAWN

Local Institution - 0018, Zagreb

NOT_YET_RECRUITING

Local Institution - 0017, Zagreb

NOT_YET_RECRUITING

Local Institution - 0019, Zagreb

NOT_YET_RECRUITING

Local Institution - 0103, Zagreb

NOT_YET_RECRUITING

Local Institution - 0129, Zagreb

10314

RECRUITING

Richmond Behavioral Associates, Staten Island

16132

NOT_YET_RECRUITING

Local Institution - 0069, Genova

20122

NOT_YET_RECRUITING

Local Institution - 0066, Milan

20708

NOT_YET_RECRUITING

Local Institution - 0152, Smila

20877

NOT_YET_RECRUITING

Local Institution - 0049, Gaithersburg

21037

NOT_YET_RECRUITING

Local Institution - 0148, Vinnytsia

25011

NOT_YET_RECRUITING

Local Institution - 0151, Kropyvnytskyi

28211

NOT_YET_RECRUITING

Local Institution - 0124, Charlotte

30030

RECRUITING

CenExel iResearch, LLC, Decatur

30328

RECRUITING

Synexus Clinical Research US, Inc., Atlanta

30331

RECRUITING

Atlanta Center for Medical Research, Atlanta

31340

NOT_YET_RECRUITING

Local Institution - 0146, Skarzhyntsi

31405

NOT_YET_RECRUITING

Local Institution - 0024, Savannah

33009

NOT_YET_RECRUITING

Local Institution - 0133, Hallandale

33016

NOT_YET_RECRUITING

Local Institution - 0026, Hialeah Gardens

RECRUITING

Innovative Clinical Research, Inc., Miami Lakes

33021

RECRUITING

Behavioral Clinical Research, Hollywood

33024

NOT_YET_RECRUITING

Local Institution - 0053, Hollywood

33126

NOT_YET_RECRUITING

Local Institution - 0030, Miami

33135

RECRUITING

Advanced Research Institute of Miami, Miami

33166

RECRUITING

South Florida Research Phase I-IV, Miami Springs

33713

NOT_YET_RECRUITING

Local Institution - 0045, St. Petersburg

34997

RECRUITING

Health Synergy Clinical Research, Stuart

36013

NOT_YET_RECRUITING

Local Institution - 0141, Poltava

39232

NOT_YET_RECRUITING

Local Institution - 0029, Flowood

44720

RECRUITING

Neuro-Behavioral Clinical Research, North Canton

45219

NOT_YET_RECRUITING

Local Institution - 0055, Cincinnati

48013

RECRUITING

Osi Bilbao-Basurto, Bilbao

49115

NOT_YET_RECRUITING

Local Institution - 0149, Dnipro

53100

NOT_YET_RECRUITING

Local Institution - 0065, Siena

56126

NOT_YET_RECRUITING

Local Institution - 0083, Pisa

60126

NOT_YET_RECRUITING

Local Institution - 0070, Ancona

60640

NOT_YET_RECRUITING

Local Institution - 0031, Chicago

60641

RECRUITING

Pillar Clinical Research -Chicago, Chicago

63141

NOT_YET_RECRUITING

Local Institution - 0042, St Louis

65006

NOT_YET_RECRUITING

Local Institution - 0144, Odesa

67512

NOT_YET_RECRUITING

Local Institution - 0145, Oleksandrivka

72204

RECRUITING

Pillar Clinical Research- Little Rock, Little Rock

72211

NOT_YET_RECRUITING

Local Institution - 0038, Little Rock

72712

RECRUITING

Pillar Clinical Research - Richardson, Bentonville

72758

NOT_YET_RECRUITING

Local Institution - 0057, Rogers

75062

WITHDRAWN

Local Institution - 0036, Irving

75080

RECRUITING

Pillar Clinical Research - Richardson, Richardson

75115

RECRUITING

InSite Clinical Research, DeSoto

76014

NOT_YET_RECRUITING

Local Institution - 0142, Ivano-Frankivsk

77021

NOT_YET_RECRUITING

Local Institution - 0046, Houston

78754

NOT_YET_RECRUITING

Local Institution - 0134, Austin

79021

NOT_YET_RECRUITING

Local Institution - 0147, Lviv

85304

NOT_YET_RECRUITING

Local Institution - 0120, Glendale

89030

NOT_YET_RECRUITING

Local Institution - 0121, North Las Vegas

WITHDRAWN

Local Institution - 0122, North Las Vegas

90230

RECRUITING

Proscience Research Group, Culver City

90504

NOT_YET_RECRUITING

Local Institution - 0123, Torrance

90703

NOT_YET_RECRUITING

Local Institution - 0044, Cerritos

90706

RECRUITING

Clinical Innovations, Inc. dba CITrials, Bellflower

91710

NOT_YET_RECRUITING

Local Institution - 0135, Chino

91763

NOT_YET_RECRUITING

Local Institution - 0056, Montclair

92506

RECRUITING

Clinical Innovations, Inc. dba CITrials, Riverside

92805

NOT_YET_RECRUITING

Local Institution - 0027, Anaheim

92868

RECRUITING

NRC Research Institute, Orange

141001

NOT_YET_RECRUITING

Local Institution - 0077, Ludhiana

390021

NOT_YET_RECRUITING

Local Institution - 0111, Vadodara

500034

NOT_YET_RECRUITING

Local Institution - 0078, Hyderabad

500082

NOT_YET_RECRUITING

Local Institution - 0080, Hyderabad

507190

NOT_YET_RECRUITING

Local Institution - 0100, Sanpetru /Brasov

590010

NOT_YET_RECRUITING

Local Institution - 0132, Belagavi

673009

NOT_YET_RECRUITING

Local Institution - 0079, Kozhikode

700014

NOT_YET_RECRUITING

Local Institution - 0076, Kolkata

700282

NOT_YET_RECRUITING

Local Institution - 0097, Iași

4534708

NOT_YET_RECRUITING

Local Institution - 0068, Hod HaSharon

4838248

NOT_YET_RECRUITING

Local Institution - 0008, Kōnan

4910002

NOT_YET_RECRUITING

Local Institution - 0084, Petah Tikva

5265601

RECRUITING

Sheba Medical Center, Ramat Gan

7410001

NOT_YET_RECRUITING

Local Institution - 0075, Ness Ziona

8461144

RECRUITING

Be'er Sheva Mental Health Center, Beersheba

9546105

NOT_YET_RECRUITING

Local Institution - 0074, Jerusalem

92845-2506

NOT_YET_RECRUITING

Local Institution - 0085, Garden Grove

06510

NOT_YET_RECRUITING

Local Institution - 0131, New Haven

08053

WITHDRAWN

Local Institution - 0058, Marlton

NOT_YET_RECRUITING

Local Institution - 0130, Marlton

C1199ABB

NOT_YET_RECRUITING

Local Institution - 0128, ABB

470-1168

RECRUITING

Okehazama Hospital, Toyoake

272-8516

RECRUITING

National Kohnodai Medical Center., Ichikawa

803-0831

WITHDRAWN

Local Institution - 0063, Kitakyushu

080-0024

RECRUITING

Obihiro Kosei Hospital, Obihiro

002-8029

RECRUITING

Goryokai Medical Corporation - Goryokai Hospital, Sapporo

590-0018

NOT_YET_RECRUITING

Local Institution - 0007, Sakai-shi

847-0031

RECRUITING

Rainbow and Sea Hospital, Karatsu-shi

350-0495

WITHDRAWN

Local Institution - 0016, 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 - 0004, Miyazaki

545-8586

RECRUITING

Osaka Metropolitan University Hospital, Osaka

570-8507

NOT_YET_RECRUITING

Local Institution - 0013, Osaka

157-8577

RECRUITING

Showa Medical University Karasuyama Hospital, Tokyo

641-8510

NOT_YET_RECRUITING

Local Institution - 0002, Wakayama

990-0045

NOT_YET_RECRUITING

Local Institution - 0014, Yamagata

0622

NOT_YET_RECRUITING

Local Institution - 0086, Auckland

61-485

NOT_YET_RECRUITING

Local Institution - 0088, Poznan

02-957

NOT_YET_RECRUITING

Local Institution - 0092, Warsaw

15-272

NOT_YET_RECRUITING

Local Institution - 0090, Bialystok

80-214

NOT_YET_RECRUITING

Local Institution - 0093, Gdansk

44-200

NOT_YET_RECRUITING

Local Institution - 0089, Rybnik

95-080

NOT_YET_RECRUITING

Local Institution - 0091, Tuszyn

041914

NOT_YET_RECRUITING

Local Institution - 0095, Bucharest

NOT_YET_RECRUITING

Local Institution - 0099, Bucharest

NOT_YET_RECRUITING

Local Institution - 0101, Bucharest

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest

060222

NOT_YET_RECRUITING

Local Institution - 0104, Bucharest

040 01

NOT_YET_RECRUITING

Local Institution - 0118, Košice

NOT_YET_RECRUITING

Local Institution - 0119, Košice

093 01

NOT_YET_RECRUITING

Local Institution - 0117, Vranov nad Topľou

08035

NOT_YET_RECRUITING

Local Institution - 0115, Barcelona

08036

RECRUITING

Hospital Clínic de Barcelona, Barcelona

131 45

RECRUITING

Nacka Local Hospital, Nacka

751 85

WITHDRAWN

Local Institution - 0112, Uppsala

413 45

WITHDRAWN

Local Institution - 0116, Gothenburg

08631

NOT_YET_RECRUITING

Local Institution - 0143, Hlevakha

04080

NOT_YET_RECRUITING

Local Institution - 0150, Kyiv

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT06929273 - A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) | Biotech Hunter | Biotech Hunter