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

Last updated: June 25, 2024
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Mood Disorders

Treatment

SEP-363856 75mg

SEP-363856 50mg

Placebo

Clinical Study ID

NCT04072354
SEP361-301
2019-000470-36
  • Ages 13-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subject between 13 to 65 years of age (inclusive) at the time ofconsent.

  2. Subject or subjects parent/legal guardian [adolescents] must give written informedconsent and privacy authorization prior to participate in the study; adolescentsmust also provide informed assent..

  3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interviewat 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 moreof 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 2months 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 screeningmedical history, PE, neurological examination, vital signs, ECG, and clinicallaboratory values.

Exclusion

Exclusion Criteria:

  1. Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5diagnosis other than schizophrenia. Exclusionary disorders include but are notlimited to alcohol use disorder (within past 12 months), substance (other thannicotine or caffeine) use disorder within past 12 months or lifetime history ofsignificant substance abuse that in the opinion of the Investigator or Sponsor, mayhave had a significant and potentially permanent impact of the brain or other bodysystems, major depressive disorder, bipolar I or II disorder, schizoaffectivedisorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptomsof mild to moderate mood dysphoria or anxiety are allowed so long as these symptomsare not the primary focus of treatment.

  2. Subject is at significant risk of harming self, others, or objects based onInvestigator's judgment.

  3. Subject has any clinically significant unstable medical condition or any clinicallysignificant chronic disease that in the opinion of the Investigator, would limit thesubject'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 asdetermined by the investigator.

Study Design

Total Participants: 463
Treatment Group(s): 3
Primary Treatment: SEP-363856 75mg
Phase: 3
Study Start date:
September 11, 2019
Estimated Completion Date:
September 12, 2023

Study 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.

Connect with a study center

  • 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, 4400
    Bulgaria

    Site Not Available

  • UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders

    Sofia, 1202
    Bulgaria

    Site Not Available

  • UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry

    Sofia, 1431
    Bulgaria

    Site Not Available

  • UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry

    Sofia, 1431
    Bulgaria

    Site Not Available

  • First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector

    Tsarev, 9747
    Bulgaria

    Site Not Available

  • Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Mental Health Center - Vratsa EOOD-Department of General Psychiatry

    Vratsa, 3000
    Bulgaria

    Site Not Available

  • E.S.E Hospital Mental de Antioquia - Unidad de Investigación

    Bello, Antioquia 051053
    Colombia

    Site Not Available

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogota,
    Colombia

    Site Not Available

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Bogota,
    Colombia

    Site Not Available

  • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

    Bogotá, 111166
    Colombia

    Site Not Available

  • State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1

    Chelyabinsk, 454087
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"

    Karelia, 186131
    Russian Federation

    Site Not Available

  • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"

    Moscow, 107076
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod

    Nizniy Novgorod, 603155
    Russian Federation

    Site Not Available

  • State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"

    Petrozavodsk, 186131
    Russian Federation

    Site Not Available

  • FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12

    Saint Petersburg, 192019
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"

    Samara, 443016
    Russian Federation

    Site Not Available

  • State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents

    Saratov, 410028
    Russian Federation

    Site Not Available

  • FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12

    St. petersburg, 092019
    Russian Federation

    Site Not Available

  • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center Nis, Center of Mental Health Protection

    Belgrade, 11000
    Serbia

    Site Not Available

  • Institute of Mental Health

    Belgrade, 11000
    Serbia

    Site Not Available

  • Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39

    Gornja Toponica, 18202
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases "Kovin",

    Kovin, 26220
    Serbia

    Site Not Available

  • Special Neuropsychiatric Hospital Kovin

    Kovin, 26220
    Serbia

    Site Not Available

  • Clinical Center Kragujevac, Clinic of Psychiatry

    Kragujevac, 34000
    Serbia

    Site Not Available

  • University Clinical Center Nis, Clinic of Psychiatry

    Nis, 18000
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases "SVeti Vracevi",

    Novi Knezevac, 23330
    Serbia

    Site Not Available

  • Clinical Center of Vojvodina, Clinic of Psychiatry

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Special Hospital for Psychiatric Diseases

    Vrsac, 26300
    Serbia

    Site Not Available

  • 15, Medychna St

    Ivano-Frankivsk, 76011
    Ukraine

    Site Not Available

  • 2-A Metalurgiv st

    Kropyvnytskyi, 25491
    Ukraine

    Site Not Available

  • 103 Kyrylivska St

    Kyiv, 04080
    Ukraine

    Site Not Available

  • Dr. Vladyslav Demchenko

    Kyiv, 02192
    Ukraine

    Site Not Available

  • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25

    Lviv, 79021
    Ukraine

    Site Not Available

  • 1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region

    Odesa, 67513
    Ukraine

    Site Not Available

  • 9 Academician Vorobiov St

    Odesa, 65006
    Ukraine

    Site Not Available

  • 1 Medychna St

    Poltava, 36013
    Ukraine

    Site Not Available

  • Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12

    Smila, 20708
    Ukraine

    Site Not Available

  • Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital

    Vinnytsia, 21005
    Ukraine

    Site Not Available

  • Woodland International Research Group, LLC

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • CITrials

    Bellflower, California 90706
    United States

    Site Not Available

  • Synergy San Diego

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Alliance for Research

    Long Beach, California 90807
    United States

    Site Not Available

  • Catalina Research Institute

    Montclair, California 91763
    United States

    Site Not Available

  • NRC Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)

    Pico Rivera, California 90660
    United States

    Site Not Available

  • UCSD Medical Center,UCSD Department of Psychiatry

    San Diego, California 92103-8229
    United States

    Site Not Available

  • Larkin Behavioral Health Services

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Research Centers of America

    Hollywood, Florida 33024
    United States

    Site Not Available

  • South Florida Research Phase I-IV, Inc.

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Advanced Discovery Research LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Atlantic Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • iResearch Atlanta, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CBH Health, LLC

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Precise Research Centers

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Arch Clinical Trials, LLC

    Saint Louis, Missouri 63125
    United States

    Site Not Available

  • Clinical Research of Southern Nevada, LLC

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Midwest Clinical Research Center

    Dayton, Ohio 45417
    United States

    Site Not Available

  • Community Clinical Research

    Austin, Texas 78754
    United States

    Site Not Available

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