A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT04092686
- Brief Summary
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
- Detailed Description
This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.
This study is designed to test the hypotheses that treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 464
- Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
- Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
- Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.
- Subject must have a CGI-S score ≥ 4
- Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
- Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
- Subject has marked deterioration of functioning in one or more areas.
- Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG and clinical laboratory values.
- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
- Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
- Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
- Female subject who is pregnant or lactating
- Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEP-363856 75mg SEP-363856 75mg SEP-363856 75mg dosed once daily Placebo Placebo Placebo dosed once daily SEP-363856 100mg SEP-363856 100mg SEP-363856 100mg dosed once daily
- Primary Outcome Measures
Name Time Method Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) Baseline and Week 6 PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) Baseline and Week 6 The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Trial Locations
- Locations (61)
Arch Clinical Trials, LLC
🇺🇸Saint Louis, Missouri, United States
Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions
🇧🇬Burgas, Bulgaria
State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women
🇧🇬Novi Iskar, Bulgaria
UMHAT Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry
🇧🇬Sofia, Bulgaria
Psychiatric Hospital "Sveti Ivan"
🇭🇷Zagreb, Croatia
SLLC Psychoneurological Hospital of Strenci
🇱🇻Strenci, Latvia
State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
🇷🇺Arkhangelsk, Russian Federation
State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166
🇷🇺Engels, Russian Federation
State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
🇷🇺Leningrad, Russian Federation
State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments
🇷🇺Saratov, Russian Federation
Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",
🇷🇺Tomsk, Russian Federation
Clinic of Psychiatry, Clinical Center of Serbia,
🇷🇸Belgrade, Serbia
Clinic of Psychiatry, Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases "Kovin"
🇷🇸Kovin, Serbia
University Clinical Center Nis, Clinic of Psychiatry
🇷🇸Nis, Serbia
46 Academician Pavlov St
🇺🇦Kharkiv, Ukraine
State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry
🇺🇦Kharkiv, Ukraine
Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
🇺🇦Kyiv, Ukraine
Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4
🇺🇦Kyiv, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20
🇺🇦Lviv, Ukraine
Communal Institution O.I. Yuschenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio
🇺🇦Vinnytsia, Ukraine
California Neuropsychopharmacology Clinical Research Institute
🇺🇸San Diego, California, United States
Larkin Behavioral Health Services
🇺🇸Hollywood, Florida, United States
Woodland Research Northwest
🇺🇸Rogers, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Clinical Innovations, Inc.
🇺🇸Bellflower, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
South Florida Research Phase I-IV, INC.
🇺🇸Miami Springs, Florida, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
CBH Health, LLC
🇺🇸Gaithersburg, Maryland, United States
Hassman Research Institute
🇺🇸Marlton, New Jersey, United States
New York State Psychiatric Institute
🇺🇸New York, New York, United States
State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment
🇧🇬Kardzhali, Bulgaria
Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental Disorders
🇧🇬Sofia, Bulgaria
LTD Psychoeurological Hospital of Daugavpils
🇱🇻Daugavpils, Latvia
SLLC Riga Centre of Psychiatry and Narcology
🇱🇻Riga, Latvia
State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"
🇷🇺Moscow, Russian Federation
State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow
🇷🇺Moscow, Russian Federation
Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add
🇷🇺Saint Petersburg, Russian Federation
Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"
🇷🇺Saint Petersburg, Russian Federation
FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3
🇷🇺Saint Petersburg, Russian Federation
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF
🇷🇺St. Petersburg, Russian Federation
Special Neuropsychiatric Hospital Kovin
🇷🇸Kovin, Serbia
Clinic of Psychiatry, clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Kragujevac, Clinic of Psychiatry
🇷🇸Kragujevac, Serbia
Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology
🇺🇦Kyiv, Ukraine
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"
🇷🇺Stavropol, Russian Federation
Clinical Center "Dr Dragisa Misovic- Dedinje"
🇷🇸Belgrade, Serbia
State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia
🇷🇺Saratov, Russian Federation
Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
🇷🇸Vrsac, Serbia
Special Hospital for Psychiatric Disease Sveti Vracevi
🇷🇸Novi Knezevac, Serbia
Special Hospital for Psychiatric Diseases "SVeti Vracevi"
🇷🇸Novi Knezevac, Serbia
Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10
🇺🇦Kherson, Ukraine
National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
🇺🇦Kyiv, Ukraine
Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,
🇺🇦Kyiv, Ukraine