A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
- Registration Number
- NCT04115319
- Brief Summary
A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.
This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.
- Detailed Description
This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult subjects with schizophrenia. This study is projected to randomize a least 300 subjects to two treatment groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study drug will be taken once a day and may be taken without food or with a light meal.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 475
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEP363856 SEP363856 SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule quetiapine XR quetiapine XR quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
- Primary Outcome Measures
Name Time Method The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation 52 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII
🇷🇴Bucuresti, Romania
Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"
🇷🇺Saint Petersburg, Russian Federation
State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"
🇷🇺Stavropol, Russian Federation
Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
🇺🇦Smila, Ukraine
Dr. Shishuka Malhorta
🇺🇸North Canton, Ohio, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Pacific Research Partners
🇺🇸Oakland, California, United States
Innovative Clinical Research
🇺🇸Miami Lakes, Florida, United States
Premier Clinical Research Institute
🇺🇸Miami, Florida, United States
Pillar Clinical Research
🇺🇸Lincolnwood, Illinois, United States
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, Russian Federation
Synexus Clinical Research US, Inc.
🇺🇸Cerritos, California, United States
Collaborative Neuroscience Network
🇺🇸Torrance, California, United States
Excell Research
🇺🇸Oceanside, California, United States
Synexus Clinical Research US
🇺🇸Atlanta, Georgia, United States
Alexian Brothers Center for Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Dean-Yurie, Altea Research
🇺🇸Las Vegas, Nevada, United States
Louisiana Clinical Research
🇺🇸Shreveport, Louisiana, United States
PsychCare Consultants Research
🇺🇸Saint Louis, Missouri, United States
Krzsztof Wroblewi-Neurobehavioral Research Inc.
🇺🇸Cedarhurst, New York, United States
Tyne Moeller-Synexus Clinical Research US Inc.
🇺🇸Jamaica, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,
🇷🇴Brasov, Romania
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",
🇷🇴Bucuresti, Romania
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie
🇷🇴Brasov, Romania
Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII
🇷🇴Bucuresti, Romania
Institutul de Psihiatrie Socola Iasi
🇷🇴Iasi, Romania
State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
🇷🇺Arkhangelsk, Russian Federation
State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"
🇷🇺Ekaterinburg, Russian Federation
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"
🇷🇺Leningrad, Russian Federation
State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"
🇷🇺Moscow, Russian Federation
Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"
🇷🇺Omsk, Russian Federation
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev"
🇷🇺Saint Petersburg, Russian Federation
Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"
🇷🇺Saint Petersburg, Russian Federation
Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF
🇷🇺Saint Petersburg, Russian Federation
S St-Petersburg state budget institution Psychoneurological dispensary #10
🇷🇺St-Petersburg, Russian Federation
Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"
🇷🇺Saint Petersburg, Russian Federation
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, Ukraine
Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic
🇺🇦Kyiv, Ukraine
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, Russian Federation
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry
🇺🇦Kharkiv, Ukraine
State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"
🇷🇺Yaroslavl, Russian Federation
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology
🇺🇦Kharkiv, Ukraine
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, Ukraine
Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry
🇺🇦Uzhgorod, Ukraine