A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

PHASE3CompletedINTERVENTIONAL
Enrollment

463

Participants

Timeline

Start Date

September 11, 2019

Primary Completion Date

May 12, 2023

Study Completion Date

September 12, 2023

Conditions
Schizophrenia
Interventions
DRUG

SEP-363856 50mg

SEP-363856 50mg tablet dosed once daily

DRUG

SEP-363856 75mg

SEP-363856 75mg tablet dosed once daily

DRUG

Placebo

Placebo tablet dosed once daily

Trial Locations (58)

1202

Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders, Sofia

1431

UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry, Sofia

UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry, Sofia

3000

Mental Health Center - Vratsa EOOD-Department of General Psychiatry, Vratsa

4400

State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman, Pazardzhik

5000

Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders, Veliko Tarnovo

5800

UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic, Pleven

11000

"Clinical Center Dr. Dragisa Misovic-Dedinje Clinic of Psychiatry", Belgrade

Clinical Center Nis, Center of Mental Health Protection, Belgrade

Institute of Mental Health, Belgrade

18000

University Clinical Center Nis, Clinic of Psychiatry, Niš

18202

Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39, Gornja Toponica

20708

Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12, Smila

20877

CBH Health, LLC, Gaithersburg

21000

Clinical Center of Vojvodina, Clinic of Psychiatry, Novi Sad

21005

Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital, Vinnytsia

23330

"Special Hospital for Psychiatric Diseases SVeti Vracevi,", Novi Kneževac

25491

2-A Metalurgiv st, Kropyvnytskyi

26220

"Special Hospital for Psychiatric Diseases Kovin,", Kovin

Special Neuropsychiatric Hospital Kovin, Kovin

26300

Special Hospital for Psychiatric Diseases, Vršac

30030

iResearch Atlanta, LLC, Decatur

30318

Advanced Discovery Research LLC, Atlanta

30331

Atlantic Center for Medical Research, Atlanta

33021

Larkin Behavioral Health Services, Hollywood

33024

Research Centers of America, Hollywood

33166

South Florida Research Phase I-IV, Inc., Miami Springs

34000

Clinical Center Kragujevac, Clinic of Psychiatry, Kragujevac

36013

1 Medychna St, Poltava

39232

Precise Research Centers, Flowood

45417

Midwest Clinical Research Center, Dayton

65006

9 Academician Vorobiov St, Odesa

67513

1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region, Odesa

72211

Woodland International Research Group, LLC, Little Rock

76011

15, Medychna St, Ivano-Frankivsk

78754

Community Clinical Research, Austin

79021

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25, Lviv

90660

California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC), Pico Rivera

90706

CITrials, Bellflower

90807

Alliance for Research, Long Beach

91763

Catalina Research Institute, Montclair

91945

Synergy San Diego, Lemon Grove

92805

Advanced Research Center, Inc., Anaheim

107076

"SBIH of Moscow Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin", Moscow

111166

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda, Bogotá

186131

"State Budgetary Healthcare Institution of Republic Karelia Republican Psyhiatric Hospital", Petrozavodsk

192019

FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12, Saint Petersburg

410028

State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents, Saratov

443016

"State Budgetary Institution of Healthcare Samara Regional Clinical Psychiatric Hospital", Samara

454087

State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1, Chelyabinsk

603155

"State Budgetary Institution of Healthcare of nizhniy Novgorod region Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod", Nizniy Novgorod

92103-8229

UCSD Medical Center,UCSD Department of Psychiatry, San Diego

051053

E.S.E Hospital Mental de Antioquia - Unidad de Investigación, Bello

Unknown

Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda, Bogotá

Centro de Investigaciones y Proyectos en Neurociencias CIPNA, Bogotá

092019

"FSBI NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12", Saint Petersburg

02192

Dr. Vladyslav Demchenko, Kyiv

04080

103 Kyrylivska St, Kyiv

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT04072354 - A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia | Biotech Hunter | Biotech Hunter