Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

PHASE3RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

June 19, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

April 30, 2026

Conditions
Bipolar Disorder, Manic
Interventions
DRUG

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily

DRUG

Placebo

Matching capsules administered orally, once daily

Trial Locations (42)

1377

RECRUITING

Clinical Site, Sofia

3000

RECRUITING

Clinical Site, Vratsa

5000

RECRUITING

Clinical Site, Veliko Tarnovo

5500

RECRUITING

Clinical Site, Lovech

6000

RECRUITING

Clinical Site, Stara Zagora

10000

RECRUITING

Clinical Site, Zagreb

10090

RECRUITING

Clinical Site, Zagreb

11000

RECRUITING

Clinical Site, Belgrade

21000

RECRUITING

Clinical Site, Split

RECRUITING

Clinical Site, Novi Sad

23330

RECRUITING

Clinical Site, Novi Kneževac

26220

RECRUITING

Clinical Site, Kovin

30030

RECRUITING

Clinical Site, Decatur

30324

RECRUITING

Clinical Site, Atlanta

30338

NOT_YET_RECRUITING

Clinical Site, Atlanta

31405

RECRUITING

Clinical Site, Savannah

32807

RECRUITING

Clinical Site, Orlando

33009

RECRUITING

Clinical Site, Hallandale

33016

RECRUITING

Clinical Site, Hialeah

RECRUITING

Clinical Site, Miami Lakes

33056

NOT_YET_RECRUITING

Clinical Site, Miami Gardens

33166

RECRUITING

Clinical Site, Miami Springs

33184

NOT_YET_RECRUITING

Clinical Site, Miami

34000

RECRUITING

Clinical Site, Kragujevac

44720

RECRUITING

Clinical Site, North Canton

71101

RECRUITING

Clinical Site, Shreveport

72758

RECRUITING

Clinical Site, Rogers

75115

RECRUITING

Clinical Site, DeSoto

78701

NOT_YET_RECRUITING

Clinical Site, Austin

78754

RECRUITING

Clinical Site, Austin

90230

RECRUITING

Clinical Site, Culver City

90706

NOT_YET_RECRUITING

Clinical Site, Bellflower

91763

RECRUITING

Clinical Site, Montclair

91945

RECRUITING

Clinical Site, Lemon Grove

92845

RECRUITING

Clinical Site, Garden Grove

141001

RECRUITING

Clinical Site, Ludhiana

422005

RECRUITING

Clinical Site, Nashik

570001

RECRUITING

Clinical Site, Mysore

575018

RECRUITING

Clinical Site, Mangalore

781032

RECRUITING

Clinical Site, Guwahati

08053

RECRUITING

Clinical Site, Marlton

Unknown

RECRUITING

Clinical Site, Rousse

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY