A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

PHASE2CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

December 5, 2016

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2018

Conditions
Schizophrenia
Interventions
DRUG

SEP-363856

One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks

DRUG

Placebo - Cap

One Placebo capsule daily for 4 weeks

Trial Locations (33)

3200

Rehabilitacios Elmegyogyaszati osztaly, Gyöngyös

5700

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula

20708

Femal Dept #11, Male Dept #12, Smila

21005

Ch of Psychiatry and Narcology, Vinnytsia

30331

Atlanta Center for Medical Research, Atlanta

46020

Ch of Neurology, Psychiatry, Narcology and MP, Ternopil

61068

Psychiatric Department of Primary Psychotic Episodes, Kharkiv

Unit of Emergency Psychiatry and Narcology, Kharkiv

65006

CI Odesa Regional Medical Center of Mental Health, Odesa

70629

Lake Charles Clinical Trials, Lake Charles

72211

Woodland International Research Group, Little Rock

73488

Dept of Psychiarty #3 (male) and #10 (female), Kherson

75080

Pillar Clinical Research, LLC, Richardson

76014

Ch of Psychiatry, Narcology and Med Psychol, Ivano-Frankivsk

Dept of Crisis Cond & Primary Psych Episode #1, Ivano-Frankivsk

88000

Dept of Psychiatry, Uzhhorod

90660

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

92845

Collaborative Neuroscience Network, LLC, Garden Grove

115522

"Federal State Budgetary Scientific Instittuion Scientific Center of Mental Health", Moscow

186131

"State Budgetary Institution of Republic Karelia Republican Psychiatric Hospital", Matrosy

188357

"Saint Petersburg State Budgetary Institution of Healthcare Psychiatric Hospital #1 named after P.P. Kashchenko", Saint Petersburg

190121

City Psychiatric Hospital of St. Nikolay Chudotvorets, Saint Petersburg

192019

FSBI Saint Petersburg Scientifc and Research Psychoneurological Instatitute named after V.M Bekhterev, Saint Petersburg

197341

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

198020

300173524, Saint Petersburg

200473

Spitalul Clinic de Neuropsihiatrie Craiova, Craiova

214019

"SBEI HPE Smolensk State Medical University of the MoH of the RF", Smolensk

410060

300151369, Saratov

620030

300195230, Yekaterinburg

700282

Institutul de Psihiatrie Socola Iasi, Sectia Clinica III Acuti, Sos. Bucium, Iași

010825

Bucharest

060222

"Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri Sfantul Stelian - C.E.T.T.T. Sf. Stelian", Bucharest

04080

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

All Listed Sponsors
lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT02969382 - A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia | Biotech Hunter | Biotech Hunter