Last updated on February 2019

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


Brief description of study

An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

Detailed Study Description

This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201.

No statistical hypothesis tests will be performed.

Clinical Study Identifier: NCT02970929

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Tibor Kelemen, MD

Bug t P l K rh z-Rendel int zet, Rehabilit ci s Elmegy gy szati Oszt ly
Gyongyos, Hungary

Jim G Aukstuolis, MD

Woodland International research Group
Little Rock, AR United States

Kashinath Yadalam, MD

Kashinath Yadalam
Lake Charles, LA United States

Scott Bartley, MD

Pillar Clinical Research, LLC
Dallas, TX United States

Raymond Manning, MD

CNRI-Los Angeles, LLC
Pico Rivera, CA United States

Robert Riesenberg, MD

Atlanta Center for Medical Research
Atlanta, GA United States

Gabor Vincze, MD

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

Daniel Vasile, aProf

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

Malina Ioana Simu, MD

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

George Mihai Badescu, MD

spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie
Craiova, Romania

Ovidiu-Eugen Alexinsch, MD

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

Anna Malakhova, MD

Sverdlov Regional Psychiatric Clinical Hospital
Ekaterinburg, Russian Federation

Boris Andreev, Prof.

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

Mikhail Popov, MD

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

Irina Ivlieva, MD

SHI Regional Clinical Psychiatry Hospital of St. Sofia
Saratov, Russian Federation

Alexander Okhapkin, Professor

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

Evgeny Snedkov, MD

City Psychiatric Hospital of St. Nikolay Chudotvorets
St. Petersburg, Russian Federation

Mikhail Ivanov, Professor

FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"
St. Petersburg, Russian Federation

Natalia Dobrovolskaya, MD

SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"
St. Petersburg, Russian Federation

Myron Mulyk, MD

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

Igor Linskiy, MD

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

Viktor Kovalenko, MD

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

Pavlo Palamarchuk, MD

CI Kherson Regional Psychiatric Hospital of Kherson RC
Kherson, Vil Stepanivka, Ukraine

Yuliya Blazhevych, MD

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

Anatolii Voloshchuk, MD

CI Odesa Regional Medical Center of Mental Health
Odesa, Ukraine

Iryna Kosenkova, MD

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

Olena Venger, MD

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

Oksana Serebrennikova, MD

Transcarpathian Regional Narcological Dispensary
Uzhgorod, Ukraine

Sofia Rymsha, Prof.

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

Recruitment Status: Closed


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