A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

PHASE3RecruitingINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

June 13, 2025

Primary Completion Date

November 2, 2026

Study Completion Date

November 2, 2026

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

KarXT

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Trial Locations (68)

0

NOT_YET_RECRUITING

Local Institution - 0057, Bucharest

10090

WITHDRAWN

Local Institution - 0009, Zagreb

NOT_YET_RECRUITING

Local Institution - 0008, Zagreb

NOT_YET_RECRUITING

Local Institution - 0010, Zagreb

NOT_YET_RECRUITING

Local Institution - 0063, Zagreb

NOT_YET_RECRUITING

Local Institution - 0078, Zagreb

16132

WITHDRAWN

Local Institution - 0040, Genova

20122

WITHDRAWN

Local Institution - 0001, Milan

20877

RECRUITING

CBH Health, Gaithersburg

28211

NOT_YET_RECRUITING

Local Institution - 0075, Charlotte

30030

RECRUITING

CenExel iResearch, LLC, Decatur

30331

RECRUITING

Atlanta Center for Medical Research, Atlanta

33016

WITHDRAWN

Local Institution - 0036, Hialeah Gardens

RECRUITING

Innovative Clinical Research, Inc., Miami Lakes

33021

RECRUITING

Behavioral Clinical Research, Hollywood

33126

RECRUITING

LCC Medical Research Institute, Miami

33166

RECRUITING

South Florida Research Phase I-IV, Miami Springs

33618

WITHDRAWN

Local Institution - 0019, Tampa

39232

NOT_YET_RECRUITING

Local Institution - 0017, Flowood

44720

RECRUITING

Neuro-Behavioral Clinical Research, North Canton

45219

RECRUITING

University of Cincinnati Medical Center, Cincinnati

48013

RECRUITING

Osi Bilbao-Basurto, Bilbao

53100

WITHDRAWN

Local Institution - 0007, Siena

56126

WITHDRAWN

Local Institution - 0056, Pisa

60126

WITHDRAWN

Local Institution - 0041, Ancona

60640

NOT_YET_RECRUITING

Local Institution - 0020, Chicago

63141

RECRUITING

Arch Clinical Trials, St Louis

72204

RECRUITING

Pillar Clinical Research- Little Rock, Little Rock

72758

RECRUITING

Woodland Research Northwest, Rogers

75080

RECRUITING

Pillar Clinical Research - Richardson, Richardson

75115

RECRUITING

InSite Clinical Research, DeSoto

77021

NOT_YET_RECRUITING

Local Institution - 0028, Houston

89030

WITHDRAWN

Local Institution - 0076, North Las Vegas

90230

RECRUITING

Proscience Research Group, Culver City

90502

RECRUITING

Collaborative Neuroscience Research, LLC, Torrance

92506

RECRUITING

Clinical Innovations, Inc. dba CITrials, Riverside

141001

NOT_YET_RECRUITING

Local Institution - 0051, Ludhiana

390021

NOT_YET_RECRUITING

Local Institution - 0065, Vadodara

500034

NOT_YET_RECRUITING

Local Institution - 0052, Hyderabad

500082

NOT_YET_RECRUITING

Local Institution - 0055, Hyderabad

507190

NOT_YET_RECRUITING

Local Institution - 0061, Sanpetru /Brasov

590010

NOT_YET_RECRUITING

Local Institution - 0082, Belagavi

673009

NOT_YET_RECRUITING

Local Institution - 0053, Kozhikode

700014

NOT_YET_RECRUITING

Local Institution - 0054, Kolkata

700282

NOT_YET_RECRUITING

Local Institution - 0047, Iași

4534708

NOT_YET_RECRUITING

Local Institution - 0042, Hod HaSharon

4910002

NOT_YET_RECRUITING

Local Institution - 0058, Petah Tikva

5265601

RECRUITING

Sheba Medical Center, Ramat Gan

7410001

NOT_YET_RECRUITING

Local Institution - 0046, Ness Ziona

8461144

RECRUITING

Be'er Sheva Mental Health Center, Beersheba

9546105

NOT_YET_RECRUITING

Local Institution - 0045, Jerusalem

08053

RECRUITING

Hassman Research Institute Marlton Site, Marlton

WITHDRAWN

Local Institution - 0031, Marlton

041914

NOT_YET_RECRUITING

Local Institution - 0049, 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

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital, Bucharest

060222

NOT_YET_RECRUITING

Local Institution - 0064, Bucharest

040 01

NOT_YET_RECRUITING

Local Institution - 0071, Košice

NOT_YET_RECRUITING

Local Institution - 0073, Košice

093 01

NOT_YET_RECRUITING

Local Institution - 0072, Vranov nad Topľou

08035

NOT_YET_RECRUITING

Local Institution - 0069, Barcelona

08036

RECRUITING

Hospital Clínic de Barcelona, Barcelona

131 45

RECRUITING

Nacka Local Hospital, Nacka

751 85

WITHDRAWN

Local Institution - 0067, Uppsala

413 45

WITHDRAWN

Local Institution - 0070, Gothenburg

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY