A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

PHASE3CompletedINTERVENTIONAL
Enrollment

475

Participants

Timeline

Start Date

November 15, 2019

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2022

Conditions
Schizophrenia
Interventions
DRUG

SEP363856

SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule

DRUG

quetiapine XR

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Trial Locations (46)

11432

Tyne Moeller-Synexus Clinical Research US Inc., Jamaica

11516

Krzsztof Wroblewi-Neurobehavioral Research Inc., Cedarhurst

14618

Finger Lakes Clinical Research, Rochester

20708

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

28211

New Hope Clinical Research, Charlotte

30328

Synexus Clinical Research US, Atlanta

33016

Innovative Clinical Research, Miami Lakes

33122

Premier Clinical Research Institute, Miami

44720

Dr. Shishuka Malhorta, North Canton

46027

Communal Non-commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Psychiatry #2 (male), Department of Psychiatry #6 (female), Ternopil I.Ya. Gorbachevskyi National Medical University of t, Ternopil

60169

Alexian Brothers Center for Psychiatric Research, Hoffman Estates

60712

Pillar Clinical Research, Lincolnwood

61068

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry, Kharkiv

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology, Kharkiv

63128

PsychCare Consultants Research, St Louis

71101

Louisiana Clinical Research, Shreveport

76011

Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8, Ivano-Frankivsk

88000

Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry, Uzhhorod

89102

Dean-Yurie, Altea Research, Las Vegas

90502

Collaborative Neuroscience Network, Torrance

90703

Synexus Clinical Research US, Inc., Cerritos

92056

Excell Research, Oceanside

92103

Artemis Institute for Clinical Research, San Diego

94607

Pacific Research Partners, Oakland

127083

"State Budgetary Healthcare Institution of Moscow Region Central Clinical Psychiatric Hospital", Moscow

150003

"State Budgetary Institution of Healthcare of Yaroslavl region Yaroslavl Regional Clinical Psychiatric Hospital", Yaroslavl

163530

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

188357

"Saint Petersburg State Budgetary Institution of Healthcare Psychiatric Hospital named after P.P. Kashchenko", Saint Petersburg

190121

S St-Petersburg state budget institution Psychoneurological dispensary #10, Saint Petersburg

"Saint Petersburg State Public Institution of Healthcare Psychiatric Hospital of Saint Nikolai Chudotvorets", Saint Petersburg

192019

"Federal State Budgetary Institution National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev MoH RF", Saint Petersburg

"Federal State Budgetary Institution National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev", Saint Petersburg

195176

"Saint Petersburg State Budgetary Institution of Healthcare City Psychoneurological Dispensary #5", Saint Petersburg

199106

"Saint Petersburg State Budgetary Institution of Healthcare Psychoneurological Dispensay No 1", Saint Petersburg

214031

"FSBEI HE Smolensk State Medical University of the MoH of the RF leg add: 28, Krupskoi str, Smolensk, Smolensk region, 214019; act add: 46-a, Kirova str, Smolensk", Smolensk

357034

"State Budgetary Institution of Healthcare of Stavropol territory Regional Specialization Psychiatry Hospital # 2", Stavropol

500079

Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,, Brasov

"Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila, Sectia Psihiatrie", Brasov

620030

"State Budgetary Institution of Heathcare of Sverdlovsk Region Sverdlovsk Regional Clinical Psychiatric Hospital", Yekaterinburg

634014

"LLC Clinic Stolet 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI Tomsk National Research Medical Center of Russian Academy of Sciences", Tomsk

644070

"Budgetary Institution of Healthcare of Omsk region Clinical Psychiatric Hospital n.a. N.N. Solodovnikov", Omsk

700282

Institutul de Psihiatrie Socola Iasi, Iași

041914

"Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Psihiatrie XII", Bucharest

060222

"Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri Sfantul Stelian,", Bucharest

41914,

Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII, Bucharest

03049

"Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC Ukrainian Railway, Consultative and Diagnostic Center of Policlinic", Kyiv

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT04115319 - A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. | Biotech Hunter | Biotech Hunter