Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

PHASE3CompletedINTERVENTIONAL
Enrollment

381

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

March 1, 2019

Study Completion Date

March 1, 2019

Conditions
Bipolar Depression
Interventions
DRUG

Lumateperone

Lumateperone 42 mg (ITI-007 60 mg tosylate)

OTHER

Placebo

Placebo

Trial Locations (47)

14215

Clinical Site, Buffalo

28211

Clinical Site, Charlotte

30030

Clinical Site, Decatur

30322

Clinical Site, Atlanta

32763

Clinical Site, Orange City

33133

Clinical Site, Miami

35294

Clinical Site, Birmingham

60435

Clinical Site, Joliet

60612

Clinical Site, Chicago

63128

Clinical Site, St Louis

71101

Clinical Site, Shreveport

77381

Clinical Site, The Woodlands

91403

Clinical Site, Sherman Oaks

98011

Clinical Site, Bothell

Unknown

Clinical Site, Burgas

Clinical Site, Kardzhali

Clinical Site, Lovech

Clinical Site, Plovdiv

Clinical Site, Rousse

Clinical Site, Sofia

Clinical Site, Targovishte

Clinical Site, Tsarev Brod

Clinical Site, Varna

Clinical Site, Veliko Tarnovo

Clinical Site, Barranquilla

Clinical Site, Bello

Clinical Site, Pereira

Clinical Site, Moscow

Clinical Site, Nizhny Novgorod

Clinical Site, Omsk

Clinical Site, Saint Petersburg

Clinical Site, Samara

Clinical Site, Saratov

Clinical Site, Tomsk

Clinical Site, Yekaterinburg

Clinical Site, Belgrade

Clinical Site, Kragujevac

Clinical Site, Novi Sad

Clinical Site, Ivano-Frankivsk

Clinical Site, Kharkiv

Clinical Site, Kherson

Clinical Site, Lviv

Clinical Site, Odesa

Clinical Site, Poltava

Clinical Site, Smila

Clinical Site, Uzhhorod

Clinical Site, Vinnytsia

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY

NCT03249376 - Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally | Biotech Hunter | Biotech Hunter