An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

812

Participants

Timeline

Start Date

October 8, 2021

Primary Completion Date

October 14, 2024

Study Completion Date

October 23, 2024

Conditions
Major Depressive Disorder
Interventions
DRUG

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily

Trial Locations (109)

1033

Clinical Site, Budapest

1083

Clinical Site, Budapest

1134

Clinical Site, Budapest

1135

Clinical Site, Budapest

1282

Clinical Site, Novi Iskar

1408

Clinical Site, Sofia

1680

Clinical Site, Sofia

3001

Clinical Site, Vratsa

3200

Clinical Site, Gyöngyös

4004

Clinical Site, Plovdiv

4032

Clinical Site, Debrecen

5000

Clinical Site, Veliko Tarnovo

5047

Clinical Site, Veliko Tarnovo

5809

Clinical Site, Pleven

6100

Clinical Site, Kazanlak

7003

Clinical Site, Rousse

7700

Clinical Site, Targovishte

8001

Clinical Site, Burgas

9747

Clinical Site, Tsarev Brod

10549

Clinical Site, Mount Kisco

11235

Clinical Site, Brooklyn

11329

Clinical Site, Stockholm

11516

Clinical Site, Cedarhurst

15355

Clinical Site, Ansan-si

18104

Clinical Site, Allentown

19053

Clinical Site, Schwerin

19063

Clinical Site, Media

19462

Clinical Site, Plymouth Meeting

20253

Clinical Site, Hamburg

20877

Clinical Site, Gaithersburg

22222

Clinical Site, Lund

26655

Clinical Site, Westerstede

28211

Clinical Site, Charlotte

30030

Clinical Site, Decatur

30328

Clinical Site, Atlanta

30329

Clinical Site, Atlanta

30331

Clinical Site, Atlanta

32256

Clinical Site, Jacksonville

32801

Clinical Site, Orlando

32905

Clinical Site, Palm Bay

33319

Clinical Site, Fort Lauderdale

33407

Clinical Site, West Palm Beach

39232

Clinical Site, Flowood

60200

Clinical Site, Brno

60435

Clinical Site, Joliet

61348

Clinical Site, Bad Homburg

61469

Clinical Site, Gwangju

63304

Clinical Site, Saint Charles

66211

Clinical Site, Overland Park

72211

Clinical Site, Little Rock

72712

Clinical Site, Bentonville

72758

Clinical Site, Rogers

78737

Clinical Site, Austin

79104

Clinical Site, Freiburg im Breisgau

82007

Clinical Site, Bratislava

85012

Clinical Site, Phoenix

90100

Clinical Site, Oulu

90230

Clinical Site, Culver City

91206

Clinical Site, Glendale

91403

Clinical Site, Sherman Oaks

91786

Clinical Site, Upland

92056

Clinical Site, Oceanside

92103

Clinical Site, San Diego

92374

Clinical Site, Redlands

92506

Clinical Site, Riverside

92660

Clinical Site, Newport Beach

92951

Clinical Site, Temecula

98007

Clinical Site, Bellevue

362001

Clinical Site, Jūnāgadh

380013

Clinical Site, Ahmedabad

390021

Clinical Site, Vadodara

400008

Clinical Site, Mumbai

422001

Clinical Site, Nashik

422005

Clinical Site, Nashik

431005

Clinical Site, Aurangabad

440010

Clinical Site, Nagpur

570001

Clinical Site, Mysore

781010

Clinical Site, Guwahati

02131

Clinical Site, Boston

08009

Clinical Site, Berlin

08755

Clinical Site, Toms River

615 00

Clinical site, Brno

253 01

Clinical Site, Hostivice

708 00

Clinical Site, Ostrava

301 00

Clinical Site, Pilsen

100 00

Clinical Site, Prague

160 00

Clinical Site, Prague

186 00

Clinical Site, Prague

00100

Clinical Site, Helsinki

09648

Clinical Site, Mittweida

97-400

Clinical Site, Bełchatów

15-404

Clinical Site, Bialystok

15-464

Clinical Site, Bialystok

15-879

Clinical Site, Bialystok

85-080

Clinical Site, Bydgoszcz

80-546

Clinical Site, Gdansk

38-300

Clinical Site, Gorlice

64-100

Clinical Site, Leszno

83-000

Clinical Site, Pruszcz Gdański

87-100

Clinical SIte, Torun

50-414

Clinical Site, Wroclaw

04001

Clinical Site, Košice

979 01

Clinical Site, Rimavská Sobota

089 01

Clinical Site, Svidník

09301

Clinical Site, Vranov nad Topľou

953 01

Clinical Site, Zlaté Moravce

01830

Clinical Site, Seoul

03080

Clinical Site, Seoul

06351

Clinical Site, Seoul

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY