A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT04072354
- 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 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.
- 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 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. 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 hypothesis 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
- 463
- Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
- Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
- Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
- 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 of 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 the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SEP-363856 50mg SEP-363856 50mg SEP-363856 50mg dosed once daily SEP-363856 75mg SEP-363856 75mg SEP-363856 75mg dosed once daily Placebo Placebo Placebo 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 (57)
Dr. Vladyslav Demchenko
🇺🇦Kyiv, Ukraine
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Advanced Discovery Research LLC
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Special Neuropsychiatric Hospital Kovin
🇷🇸Kovin, Serbia
Special Hospital for Psychiatric Diseases
🇷🇸Vrsac, Serbia
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
🇨🇴Bogotá, Colombia
Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
🇷🇸Gornja Toponica, Serbia
Special Hospital for Psychiatric Diseases "Kovin",
🇷🇸Kovin, Serbia
Community Clinical Research
🇺🇸Austin, Texas, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)
🇺🇸Pico Rivera, California, United States
Synergy San Diego
🇺🇸Lemon Grove, California, United States
Research Centers of America
🇺🇸Hollywood, Florida, United States
Woodland International Research Group, LLC
🇺🇸Little Rock, Arkansas, United States
State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1
🇷🇺Chelyabinsk, Russian Federation
State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
🇷🇺Petrozavodsk, Russian Federation
Clinical Center Kragujevac, Clinic of Psychiatry
🇷🇸Kragujevac, Serbia
Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
🇧🇬Sofia, Bulgaria
UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry
🇧🇬Sofia, Bulgaria
Alliance for Research
🇺🇸Long Beach, California, United States
CITrials
🇺🇸Bellflower, California, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
UCSD Medical Center,UCSD Department of Psychiatry
🇺🇸San Diego, California, United States
Larkin Behavioral Health Services
🇺🇸Hollywood, Florida, United States
South Florida Research Phase I-IV, Inc.
🇺🇸Miami Springs, Florida, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
CBH Health, LLC
🇺🇸Gaithersburg, Maryland, United States
UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry
🇧🇬Sofia, Bulgaria
State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman
🇧🇬Pazardzhik, Bulgaria
UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
🇧🇬Pleven, Bulgaria
Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
🇧🇬Veliko Tarnovo, Bulgaria
E.S.E Hospital Mental de Antioquia - Unidad de Investigación
🇨🇴Bello, Antioquia, Colombia
Mental Health Center - Vratsa EOOD-Department of General Psychiatry
🇧🇬Vratsa, Bulgaria
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
🇨🇴Bogota, Colombia
State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
🇷🇺Nizniy Novgorod, Russian Federation
SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
🇷🇺Moscow, Russian Federation
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
🇷🇸Belgrade, Serbia
State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
🇷🇺Saratov, Russian Federation
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
🇷🇺St. petersburg, Russian Federation
Clinical Center Nis, Center of Mental Health Protection
🇷🇸Belgrade, Serbia
FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
🇷🇺Saint Petersburg, Russian Federation
State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
🇷🇺Samara, Russian Federation
Institute of Mental Health
🇷🇸Belgrade, Serbia
University Clinical Center Nis, Clinic of Psychiatry
🇷🇸Nis, Serbia
Special Hospital for Psychiatric Diseases "SVeti Vracevi",
🇷🇸Novi Knezevac, Serbia
Clinical Center of Vojvodina, Clinic of Psychiatry
🇷🇸Novi Sad, Serbia
15, Medychna St
🇺🇦Ivano-Frankivsk, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
🇺🇦Lviv, Ukraine
103 Kyrylivska St
🇺🇦Kyiv, Ukraine
9 Academician Vorobiov St
🇺🇦Odesa, Ukraine
Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
🇺🇦Smila, Ukraine
1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
🇺🇦Odesa, Ukraine
1 Medychna St
🇺🇦Poltava, Ukraine
Atlantic Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital
🇺🇦Vinnytsia, Ukraine
2-A Metalurgiv st
🇺🇦Kropyvnytskyi, Ukraine