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

PHASE3CompletedINTERVENTIONAL
Enrollment

464

Participants

Timeline

Start Date

September 30, 2019

Primary Completion Date

June 14, 2023

Study Completion Date

June 14, 2023

Conditions
Schizophrenia
Interventions
DRUG

SEP-363856 75mg

SEP-363856 75mg tablet dosed once daily

DRUG

SEP-363856 100mg

SEP-363856 100mg tablet dosed once daily

DRUG

Placebo

Placebo tablet dosed once daily

Trial Locations (62)

1202

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

1282

"State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults closed Type -Men, Department General Psychiatry for Adults, Closed Type - Women", Novi Iskar

1431

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

4000

UMHAT Sveti Georgi EAD, Plovdiv

6600

State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment, Kardzhali

8000

Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions, Burgas

10032

New York State Psychiatric Institute, New York

10090

"Psychiatric Hospital Sveti Ivan", Zagreb

11000

Clinic of Psychiatry, Clinical Center of Serbia,, Belgrade

Clinic of Psychiatry, Clinical Center of Serbia, Belgrade

"Clinical Center Dr Dragisa Misovic- Dedinje", Belgrade

18000

University Clinical Center Nis, Clinic of Psychiatry, Niš

20877

CBH Health, LLC, Gaithersburg

21005

Communal Institution O.I. Yuschenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio, Vinnytsia

23330

Special Hospital for Psychiatric Disease Sveti Vracevi, Novi Kneževac

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

26220

"Special Hospital for Psychiatric Diseases Kovin", Kovin

Special Neuropsychiatric Hospital Kovin, Kovin

26300

"Special Hospital for Psychiatric Diseases Dr Slavoljub Bakalovic", Vršac

30030

iResearch Atlanta, LLC, Decatur

30331

Atlanta Center for Medical Research, Atlanta

33021

Larkin Behavioral Health Services, Hollywood

33166

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

34000

Clinic of Psychiatry, clinical Center Kragujevac, Kragujevac

University Clinical Center Kragujevac, Clinic of Psychiatry, Kragujevac

60641

Pillar Clinical Research, Chicago

61068

46 Academician Pavlov St, Kharkiv

State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry, Kharkiv

63125

Arch Clinical Trials, LLC, St Louis

70629

Lake Charles Clinical Trials, Lake Charles

72758

Woodland Research Northwest, Rogers

73488

Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10, Kherson

75080

Pillar Clinical Research, Richardson

79021

Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20, Lviv

90230

ProScience Research Group, Culver City

90706

Clinical Innovations, Inc., Bellflower

90806

Collaborative Neuroscience Network, Long Beach

91403

Schuster Medical Research Institute, Sherman Oaks

92102

California Neuropsychopharmacology Clinical Research Institute, San Diego

92805

Advanced Research Center, Inc., Anaheim

117152

"State Budgetary Institution of Healthcare of Moscow Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow", Moscow

141371

"State Budgetary Institution of Healthcare of Moscow Psychiatric Hospital No. 5", Moscow

163530

"State Budgetary Healthcare Institution of Arkhangelsk region Arkhangelsk clinical psychiatric hospital", Arkhangelsk

188820

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary, Saint Petersburg

190005

"Saint Petersburg State Budgetary Institution of Healthcare Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add", Saint Petersburg

192019

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

"FSBI- NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF3", Saint Petersburg

197341

"Saint Petersburg State Public Institution of Healthcare City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov", Saint Petersburg

357034

"State Budgetary Healthcare Institution of Stavropol region Stavropol Region Psychiatric Hospital # 2", Stavropol

410028

"State Institution of Healthcare Saratov City Clinical Hospital #2 named after V.I. Razumovskiy 20 and 21 departments", Saratov

410060

State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia, Saratov

413124

"State Healthcare Institution Psychiatric Hospital of Engels of MoH of Saratov Region, departments № 1 and 3, 166", Engel's

634014

"Federal State Budgetary Scientific Institution Tomsk National Research Medical Center of Russian Academy of Sciences,", Tomsk

08053

Hassman Research Institute, Marlton

LV-5417

LTD Psychoeurological Hospital of Daugavpils, Daugavpils

LV-1005

SLLC Riga Centre of Psychiatry and Narcology, Riga

LV-4730

SLLC Psychoneurological Hospital of Strenci, Strenči

01030

"Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC Ukrainian railway Department of Psychoneurology", Kyiv

01133

National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients, Kyiv

08631

Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2, Kyiv

Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,, Kyiv

Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4, Kyiv

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia | Biotech Hunter | Biotech Hunter