Study of Lumateperone in the Treatment of Patients With Bipolar Mania

PHASE3RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

July 17, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

June 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 (35)

1431

RECRUITING

Clinical Site, Sofia

4002

RECRUITING

Clinical Site, Plovdiv

6100

RECRUITING

Clinical Site, Kazanlak

8000

RECRUITING

Clinical Site, Burgas

8800

RECRUITING

Clinical Site, Sliven

11000

RECRUITING

Clinical Site, Belgrade

11004

NOT_YET_RECRUITING

Clinical Site, Glen Oaks

20877

RECRUITING

Clinical Site, Gaithersburg

26220

RECRUITING

Clinical Site, Kovin

30281

RECRUITING

Clinical Site, Stockbridge

30331

RECRUITING

Clinical Site, Atlanta

33012

RECRUITING

Clinical Site, Hialeah

33014

RECRUITING

Clinical Site, Miami Lakes

33016

RECRUITING

Clinical Site, Miami Lakes

33122

RECRUITING

Clinical Site, Miami

33135

RECRUITING

Clinical Site, Miami

33145

RECRUITING

Clinical Site, Miami

33407

RECRUITING

Clinical Site, West Palm Beach

33629

RECRUITING

Clinical Site, Tampa

34000

RECRUITING

Clinical Site, Kragujevac

45219

NOT_YET_RECRUITING

Clinical Site, Cincinnati

60640

RECRUITING

Clinical Site, Chicago

60641

RECRUITING

Clinical Site, Chicago

72211

RECRUITING

Clinical Site, Little Rock

72712

RECRUITING

Clinical Site, Bentonville

75080

RECRUITING

Clinical Site, Richardson

90504

RECRUITING

Clinical Site, Torrance

90703

RECRUITING

Clinical Site, Cerritos

92805

RECRUITING

Clinical Site, Anaheim

92868

RECRUITING

Clinical Site, Orange

507190

RECRUITING

Clinical Site, Brasov

700282

RECRUITING

Clinical Site, Iași

06022

RECRUITING

Clinical Site, Bucharest

Unknown

RECRUITING

Clinical Site, Niš

RECRUITING

Clinical Site, Novi Kneževac

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY