A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: SEP-363856 50mg; Drug: SEP-363856 75mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Pazardzhik, Bulgaria, 4400
    • 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
  • Pleven, Bulgaria, 5800
    • UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
  • Sofia, Bulgaria, 1202
    • Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry
  • Veliko Tarnovo, Bulgaria, 5000
    • Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
  • Vratsa, Bulgaria, 3000
    • Mental Health Center - Vratsa EOOD-Department of General Psychiatry
• Colombia
  • Bogota, Colombia
    • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
  • Bogota, Colombia
    • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
  • Bogotá, Colombia, 111166
    • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
  • Antioquia
    • Bello, Antioquia, Colombia, 051053
      • E.S.E Hospital Mental de Antioquia - Unidad de Investigación
• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
    • State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1
  • Moscow, Russian Federation, 107076
    • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
  • Nizniy Novgorod, Russian Federation, 603155
    • State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
  • Petrozavodsk, Russian Federation, 186131
    • State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
  • Saint Petersburg, Russian Federation, 192019
    • FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
  • Samara, Russian Federation, 443016
    • State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
  • Saratov, Russian Federation, 410028
    • State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
  • St. petersburg, Russian Federation, 092019
    • FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
• Serbia
  • Belgrade, Serbia, 11000
    • Institute of Mental Health
  • Belgrade, Serbia, 11000
    • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
  • Belgrade, Serbia, 11000
    • Clinical Center Nis, Center of Mental Health Protection
  • Gornja Toponica, Serbia, 18202
    • Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
  • Kovin, Serbia, 26220
    • Special Neuropsychiatric Hospital Kovin
  • Kovin, Serbia, 26220
    • Special Hospital for Psychiatric Diseases "Kovin",
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac, Clinic of Psychiatry
  • Nis, Serbia, 18000
    • University Clinical Center Nis, Clinic of Psychiatry
  • Novi Knezevac, Serbia, 23330
    • Special Hospital for Psychiatric Diseases "SVeti Vracevi",
  • Novi Sad, Serbia, 21000
    • Clinical Center of Vojvodina, Clinic of Psychiatry
  • Vrsac, Serbia, 26300
    • Special Hospital for Psychiatric Diseases
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76011
    • 15, Medychna St
  • Kropyvnytskyi, Ukraine, 25491
    • 2-A Metalurgiv st
  • Kyiv, Ukraine, 02192
    • Dr. Vladyslav Demchenko
  • Kyiv, Ukraine, 04080
    • 103 Kyrylivska St
  • Lviv, Ukraine, 79021
    • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
  • Odesa, Ukraine, 65006
    • 9 Academician Vorobiov St
  • Odesa, Ukraine, 67513
    • 1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
  • Poltava, Ukraine, 36013
    • 1 Medychna St
  • Smila, Ukraine, 20708
    • Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
  • Vinnytsia, Ukraine, 21005
    • Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group, LLC
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc.
    • Bellflower, California, United States, 90706
      • CiTrials
    • Lemon Grove, California, United States, 91945
      • Synergy San Diego
    • Long Beach, California, United States, 90807
      • Alliance for Research
    • Montclair, California, United States, 91763
      • Catalina Research Institute
    • Pico Rivera, California, United States, 90660
      • California Neuropsychopharmacology Clinical research Institute (CNRI-LA, LLC)
    • San Diego, California, United States, 92103-8229
      • UCSD Medical Center,UCSD Department of Psychiatry
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America
    • Hollywood, Florida, United States, 33021
      • Larkin Behavioral Health Services
    • Miami Springs, Florida, United States, 33166
      • South Florida Research Phase I-Iv, Inc.
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlantic Center for Medical Research
    • Atlanta, Georgia, United States, 30318
      • Advanced Discovery Research LLC
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
      • CBH Health, LLC
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78754
      • Community Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
2. 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..
3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
4. Subject must have a CGI-S score ≥ 4
5. 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
6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
7. Subject has marked deterioration of functioning in one or more areas.
8. 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.

Exclusion Criteria:

1. 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.
2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
3. 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:
4. Female subject who is pregnant or lactating
5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEP-363856 50mg; SEP-363856 50mg dosed once daily	Drug: SEP-363856 50mg; SEP-363856 50mg tablet dosed once daily
Experimental: SEP-363856 75mg; SEP-363856 75mg dosed once daily	Drug: SEP-363856 75mg; SEP-363856 75mg tablet dosed once daily
Placebo Comparator: Placebo; Placebo dosed once daily	Drug: Placebo; Placebo tablet dosed once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (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.	Baseline and Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (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.	Baseline and Week 6

Collaborators and Investigators

• Sponsor: Sumitomo Pharma America, Inc.
• Investigators: Study Chair: CNS Medical Director, Sunovion Pharmaceuticals In.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2019
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: schizophrenia; acute psychosis
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: SEP361-301; 2019-000470-36 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study may be made available upon request via the Vivli Global Center for Clinical Research Data site.
• IPD Sharing Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No