Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

July 30, 2021

Primary Completion Date

February 22, 2024

Study Completion Date

February 27, 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 (54)

1033

Clinical Site, Budapest

1083

Clinical Site, Budapest

1134

Clinical Site, Budapest

3001

Clinical Site, Vratsa

3200

Clinical Site, Gyöngyös

5000

Clinical Site, Veliko Tarnovo

5047

Clinical Site, Veliko Tarnovo

5809

Clinical Site, Pleven

6100

Clinical Site, Kazanlak

7003

Clinical Site, Rousse

8001

Clinical Site, Burgas

9747

Clinical Site, Tsarev Brod

11516

Clinical Site, Cedarhurst

30030

Clinical Site, Decatur

32256

Clinical Site, Jacksonville

32801

Clinical Site, Orlando

33319

Clinical Site, Fort Lauderdale

60200

Clinical Site, Brno

70800

Clinical Site, Ostrava

78737

Clinical Site, Austin

82007

Clinical Site, Bratislava

85012

Clinical Site, Phoenix

91206

Clinical Site, Glendale

91786

Clinical Site, Upland

92056

Clinical Site, Oceanside

92374

Clinical Site, Redlands

92591

Clinical Site, Temecula

141001

Clinical Site, Ludhiana

221005

Clinical Site, Varanasi

226003

Clinical Site, Lucknow

302017

Clinical Site, Jaipur

362001

Clinical Site, Jūnāgadh

380013

Clinical Site, Ahmedabad

390021

Clinical Site, Vadodara

422005

Clinical Site, Nashik

422101

Clinical Site, Nashik

431005

Clinical Site, Aurangabad

440010

Clinical Site, Nagpur

570001

Clinical Site, Mysore

575003

Clinical Site, Mangaluru

673009

Clinical Site, Kozhikode

781011

Clinical Site, Guwahati

02131

Clinical Site, Boston

08009

Clinical Site, Berlin

08755

Clinical Site, Toms River

615 000

Clinical Site, Brno

301 00

Clinical site, Pilsen

160 00

Clinical Site, Prague

186 00

Clinical Site, Prague

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

Sponsors
All Listed Sponsors
lead

Intra-Cellular Therapies, Inc.

INDUSTRY

NCT04985942 - Clinical Trial of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder | Biotech Hunter | Biotech Hunter