Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

September 30, 2021

Primary Completion Date

April 12, 2024

Study Completion Date

April 12, 2024

Conditions
Major Depressive Disorder
Interventions
DRUG

Lumateperone

Lumateperone 42 mg capsules administered orally, once daily.

DRUG

Placebo

Matching capsules administered orally, once daily.

Trial Locations (50)

1408

Clinical Site, Sofia

1680

Clinical Site, Sofia

4004

Clinical Site, Plovdiv

5000

Clinical Site, Córdoba

5009

Clinical Site, Córdoba

7700

Clinical Site, Targovishte

11235

Clinical Site, Brooklyn

11329

Clinical Site, Stockholm

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

30329

Clinical Site, Atlanta

32905

Clinical Site, Palm Bay

33407

Clinical Site, West Palm Beach

39232

Clinical Site, Flowood

61348

Clinical Site, Bad Homburg

66211

Clinical Site, Overland Park

72211

Clinical Site, Little Rock

72758

Clinical Site, Rogers

79104

Clinical site, Freiburg im Breisgau

90100

Clinical Site, Oulu

92103

Clinical Site, San Diego

92506

Clinical Site, Riverside

92660

Clinical Site, Newport Beach

98007

Clinical Site, Bellevue

1058 AAJ

Clinical Site, Buenos Aires

5000FJF

Clinical Site, Córdoba

X5003DCE

Clinical Site, Córdoba

M5502AHV

Clinical Site, Mendoza

S2000QJI

Clinical Site, Rosario

C10154ABQ

Clinical Site, Buenos Aires

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

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY

NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Biotech Hunter | Biotech Hunter