A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

ClinicalTrials.gov processed this data on June 26, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified June 2024 by Otsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Information Provided by (Responsible Party)

Otsuka Pharmaceutical Development & Commercialization, Inc.

Clinicaltrials.gov Identifier

NCT04115319
Other Study ID Numbers: SEP361-304
First Submitted: October 2, 2019
First Posted: October 4, 2019
Last Update Posted: June 28, 2024
Last Verified: June 2024
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Schizophrenia
  • Drug: SEP363856
  • Drug: quetiapine XR

Study Design

Study TypeInterventional
Actual Enrollment475 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Study Start DateNovember 15, 2019
Actual Primary Completion DateDecember 30, 2022
Actual Study Completion DateDecember 30, 2022

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • SEP363856
    • SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule
  • Drug: SEP363856
    • SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
  • quetiapine XR
    • quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
  • Drug: quetiapine XR

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation [52 Weeks]

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 65 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • The main inclusion criteria include, but are not limited to the following:
    • Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
    • Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.
    • Subject must have a CGI-S score ≤ 4 at Screening and Baseline.
    • Subject must have a PANSS total score ≤ 80 at Screening and Baseline.
    • Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
    • Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
    • Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
    • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).
    Exclusion Criteria
    • Main exclusion criteria include, but are not limited to:
    • Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
    • Subject has a current 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, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment.
    • Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks.
    • Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Screening (i.e., in the past one month) or at Baseline (i.e., since last visit).
    • Subject is at significant risk of harming self or others based on Investigator's judgment.
    • Subject has attempted suicide within 6 months prior to Screening.
    • Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer)
    • Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR.
    • 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.
    • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

    Contacts and Locations

    Sponsors and Collaborators Otsuka Pharmaceutical Development & Commercialization, Inc.
    Locations
    • Synexus Clinical Research US, Inc. | Cerritos, California, United States, 90703
    • Pacific Research Partners | Oakland, California, United States, 94607
    • Excell Research | Oceanside, California, United States, 92056
    • Artemis Institute for Clinical Research | San Diego, California, United States, 92103
    • Collaborative Neuroscience Network | Torrance, California, United States, 90502
    • Innovative Clinical Research | Miami Lakes, Florida, United States, 33016
    • Premier Clinical Research Institute | Miami, Florida, United States, 33122
    • Synexus Clinical Research US | Atlanta, Georgia, United States, 30328
    • Alexian Brothers Center for Psychiatric Research | Hoffman Estates, Illinois, United States, 60169
    • Pillar Clinical Research | Lincolnwood, Illinois, United States, 60712
    • Louisiana Clinical Research | Shreveport, Louisiana, United States, 71101
    • PsychCare Consultants Research | Saint Louis, Missouri, United States, 63128
    • Dean-Yurie, Altea Research | Las Vegas, Nevada, United States, 89102
    • Krzsztof Wroblewi-Neurobehavioral Research Inc. | Cedarhurst, New York, United States, 11516
    • Tyne Moeller-Synexus Clinical Research US Inc. | Jamaica, New York, United States, 11432
    • Finger Lakes Clinical Research | Rochester, New York, United States, 14618
    • New Hope Clinical Research | Charlotte, North Carolina, United States, 28211
    • Dr. Shishuka Malhorta | North Canton, Ohio, United States, 44720
    • Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu, | Brasov, Romania, 500079
    • Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie | Brasov, Romania, 500079
    • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII | Bucuresti, Romania, 041914
    • Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", | Bucuresti, Romania, 060222
    • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII | Bucuresti, Romania, 41914,
    • Institutul de Psihiatrie Socola Iasi | Iasi, Romania, 700282
    • State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital" | Arkhangelsk, Russian Federation, 163530
    • State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital" | Ekaterinburg, Russian Federation, 620030
    • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko" | Leningrad, Russian Federation, 188357
    • State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital" | Moscow, Russian Federation, 127083
    • Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov" | Omsk, Russian Federation, 644070
    • Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets" | Saint Petersburg, Russian Federation, 190121
    • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF | Saint Petersburg, Russian Federation, 192019
    • Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" | Saint Petersburg, Russian Federation, 192019
    • Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5" | Saint Petersburg, Russian Federation, 195176
    • Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1" | Saint Petersburg, Russian Federation, 199106
    • 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, 214031
    • S St-Petersburg state budget institution Psychoneurological dispensary #10 | St-Petersburg, Russian Federation, 190121
    • State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2" | Stavropol, Russian Federation, 357034
    • 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, 634014
    • State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital" | Yaroslavl, Russian Federation, 150003
    • 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, 76011
    • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry | Kharkiv, Ukraine, 61068
    • State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology | Kharkiv, Ukraine, 61068
    • Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic | Kyiv, Ukraine, 03049
    • Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12 | Smila, Ukraine, 20708
    • 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, 46027
    • Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry | Uzhgorod, Ukraine, 88000

    More Information

    Additional Relevant MeSH Terms

    • Schizophrenia
    • Schizophrenia Spectrum and Other Psychotic Disorders
    • Mental Disorders