NCT07140913View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL

Enrollment

424

Participants

Timeline

Start Date

October 8, 2025

Primary Completion Date

June 28, 2027

Study Completion Date

June 28, 2027

Conditions

ManiaBipolar Disorder

Interventions

DRUG

Xanomeline/Trospium Chloride

Specified dose on specified days

DRUG

Lithium

Specified dose on specified days

DRUG

Valproate

Specified dose on specified days

DRUG

Lamotrigine

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Trial Locations (66)

0

NOT_YET_RECRUITING

Local Institution - 0099, Bucharest

1282

NOT_YET_RECRUITING

Local Institution - 0124, Novi Iskar

2600

NOT_YET_RECRUITING

Local Institution - 0091, Glostrup Municipality

3400

NOT_YET_RECRUITING

Local Institution - 0088, Hillerød

4000

NOT_YET_RECRUITING

Local Institution - 0125, Plovdiv

4200

NOT_YET_RECRUITING

Local Institution - 0114, Santiago del Estero

5000

NOT_YET_RECRUITING

Local Institution - 0010, Córdoba

NOT_YET_RECRUITING

Local Institution - 0012, Córdoba

5502

NOT_YET_RECRUITING

Local Institution - 0009, Mendoza

5800

NOT_YET_RECRUITING

Local Institution - 0084, Pleven

7700

NOT_YET_RECRUITING

Local Institution - 0086, Targovishte

9000

NOT_YET_RECRUITING

Local Institution - 0054, Aalborg

10314

NOT_YET_RECRUITING

Local Institution - 0032, Staten Island

13274

NOT_YET_RECRUITING

Local Institution - 0087, Marseille

16132

NOT_YET_RECRUITING

Local Institution - 0002, Genova

20122

NOT_YET_RECRUITING

Local Institution - 0003, Milan

30200

NOT_YET_RECRUITING

Local Institution - 0090, Tirat Carmel

31405

NOT_YET_RECRUITING

Local Institution - 0136, Savannah

33009

NOT_YET_RECRUITING

Local Institution - 0015, Hallandale

33166

NOT_YET_RECRUITING

Local Institution - 0021, Miami Springs

34997

NOT_YET_RECRUITING

Local Institution - 0016, Stuart

53100

NOT_YET_RECRUITING

Local Institution - 0001, Siena

56126

NOT_YET_RECRUITING

Local Institution - 0005, Pisa

60126

NOT_YET_RECRUITING

Local Institution - 0004, Ancona

60641

RECRUITING

Pillar Clinical Research -Chicago, Chicago

63000

NOT_YET_RECRUITING

Local Institution - 0085, Clermont-Ferrand

63141

NOT_YET_RECRUITING

Local Institution - 0023, St Louis

72204

RECRUITING

Pillar Clinical Research- Little Rock, Little Rock

72712

RECRUITING

Pillar Clinical Research - Bentonville, Bentonville

75014

NOT_YET_RECRUITING

Local Institution - 0089, Paris

75080

RECRUITING

Pillar Clinical Research - Richardson, Richardson

76063

NOT_YET_RECRUITING

Local Institution - 0156, Mansfield

77702

NOT_YET_RECRUITING

Local Institution - 0160, Beaumont

78754

NOT_YET_RECRUITING

Local Institution - 0026, Austin

90230

NOT_YET_RECRUITING

Local Institution - 0014, Culver City

91710

NOT_YET_RECRUITING

Local Institution - 0049, Chino

91763

NOT_YET_RECRUITING

Local Institution - 0037, Montclair

92506

NOT_YET_RECRUITING

Local Institution - 0110, Riverside

92626

NOT_YET_RECRUITING

Local Institution - 0106, Costa Mesa

92868

NOT_YET_RECRUITING

Local Institution - 0148, Orange

500123

NOT_YET_RECRUITING

Local Institution - 0095, Brașov

550082

NOT_YET_RECRUITING

Local Institution - 0101, Sibiu

625020

NOT_YET_RECRUITING

Local Institution - 0123, Madurai

700282

NOT_YET_RECRUITING

Local Institution - 0097, Iași

4534708

NOT_YET_RECRUITING

Local Institution - 0052, Hod HaSharon

5265601

NOT_YET_RECRUITING

Local Institution - 0050, Ramat Gan

7410001

NOT_YET_RECRUITING

Local Institution - 0051, Ness Ziona

7830604

NOT_YET_RECRUITING

Local Institution - 0053, Ashkelon

8078555

NOT_YET_RECRUITING

Local Institution - 0141, Kitakyushu-shi

9112001

NOT_YET_RECRUITING

Local Institution - 0083, Jerusalem

90631-3842

NOT_YET_RECRUITING

Local Institution - 0151, La Habra

C1199ABB

NOT_YET_RECRUITING

Local Institution - 0011, ABB

X5003DCE

NOT_YET_RECRUITING

Local Institution - 0008, Córdoba

966-0902

NOT_YET_RECRUITING

Local Institution - 0172, Kitakata

002-8029

NOT_YET_RECRUITING

Local Institution - 0108, Sapporo

234-0051

NOT_YET_RECRUITING

Local Institution - 0107, Yokohama

781-8555

NOT_YET_RECRUITING

Local Institution - 0142, Kochi

113-8603

NOT_YET_RECRUITING

Local Institution - 0139, Bunkyo-ku

44-200

NOT_YET_RECRUITING

Local Institution - 0103, Rybnik

95-080

NOT_YET_RECRUITING

Local Institution - 0082, Tuszyn

011241

NOT_YET_RECRUITING

Local Institution - 0102, Bucharest

041914

NOT_YET_RECRUITING

Local Institution - 0092, Bucharest

NOT_YET_RECRUITING

Local Institution - 0093, Bucharest

NOT_YET_RECRUITING

Local Institution - 0094, Bucharest

NOT_YET_RECRUITING

Local Institution - 0098, Bucharest

060222

NOT_YET_RECRUITING

Local Institution - 0096, Bucharest

Sponsors

Lead Sponsor

Bristol-Myers Squibb

All Listed Sponsors

lead

Bristol-Myers Squibb

INDUSTRY

NCT07140913 - 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 | Biotech Hunter | Biotech Hunter