An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

PHASE2CompletedINTERVENTIONAL
Enrollment

157

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

January 29, 2019

Study Completion Date

January 29, 2019

Conditions
Schizophrenia
Interventions
DRUG

SEP-363856

One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks

Trial Locations (30)

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly, Gyula

20708

CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12, Smila

21005

CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU, Vinnytsia

30331

Atlanta Center for Medical Research, Atlanta

46020

Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU, Ternopil

61068

CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology, Kharkiv

CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod, Kharkiv

65006

CI Odesa Regional Medical Center of Mental Health, Odesa

70629

Kashinath Yadalam, Lake Charles

72211

Woodland International research Group, Little Rock

73488

CI Kherson Regional Psychiatric Hospital of Kherson RC, Kherson

75243

Pillar Clinical Research, LLC, Dallas

76014

Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1, Ivano-Frankivsk

88000

Transcarpathian Regional Narcological Dispensary, Uzhhorod

90660

CNRI-Los Angeles, LLC, Pico Rivera

188357

St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko, Gatchina

190121

City Psychiatric Hospital of St. Nikolay Chudotvorets, Saint Petersburg

192019

"FB=SBISaint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev", Saint Petersburg

197341

"SPHI City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov", Saint Petersburg

198020

"SPb SBIH City Psychoneurological Dispensary #7 (with inpatient facilities)", Saint Petersburg

200473

spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie, Craiova

214019

"FSBEI HE Smolensk State Medical University of the MoH of the RF", Smolensk

410060

SHI Regional Clinical Psychiatry Hospital of St. Sofia, Saratov

620030

Sverdlov Regional Psychiatric Clinical Hospital, Yekaterinburg

700282

Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti, Iași

92103-8229

UCSD Medical Center UCSD Department of Psychiatry, San Diego

út 20-22

Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály, Gyöngyös

010825

"Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila", Bucharest

060222

"Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri Sf. Stelian, Sectia Psihiatrie", Bucharest

04080

TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions, Kyiv

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02970929 - An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia | Biotech Hunter | Biotech Hunter