Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

February 27, 2020

Primary Completion Date

November 30, 2022

Study Completion Date

November 30, 2022

Conditions
Bipolar DepressionMajor Depressive Disorder
Interventions
DRUG

Lumateperone

Lumateperone 42mg oral capsule

DRUG

Placebos

Placebo oral capsule

Trial Locations (42)

1113

Clinical Site, Sofia

1133

Clinical Site, Kyiv

1408

Clinical Site, Sofia

1431

Clinical Site, Sofia

1680

Clinical Site, Sofia

3000

Clinical Site, Vratsa

4004

Clinical Site, Plovdiv

5000

Clinical Site, Veliko Tarnovo

6600

Clinical Site, Kardzhali

7003

Clinical Site, Rousse

8000

Clinical Site, Burgas

9020

Clinical Site, Varna

10128

Clinical Site, New York

11000

Clinical Site, Belgrade

11694

Clinical Site, Cedarhurst

20708

Clinical Site, Smila

21005

Clinical Site, Vinnytsia

26220

Clinical Site, Kovin

28211

Clinical Site, Charlotte

30030

Clinical Site, Decatur

30331

Clinical Site, Atlanta

32763

Clinical Site, Orange City

33122

Clinical Site, Miami

33319

Clinical Site, Lauderhill

34000

Clinical Site, Kragujevac

36013

Clinical Site, Poltava

63368

Clinical Site, O'Fallon

65006

Clinical site, Odesa

67513

Clinical Site, Odesa

79021

Clinical Site, Lviv

91403

Clinical Site, Sherman Oaks

92056

Clinical Site, Oceanside

92845

Clinical Site, Garden Grove

98007

Clinical Site, Bellevue

105082

Clinical Site, Moscow

190121

Clinical Site, Saint Petersburg

192019

Clinical Site, Saint Petersburg

195160

Clinical Site, Saint Petersburg

197341

Clinical Site, Saint Petersburg

199106

Clinical Site, Saint Petersburg

620030

Clinical Site, Yekaterinburg

634009

Clinical Site, Tomsk

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY

NCT04285515 - Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder | Biotech Hunter | Biotech Hunter