A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

December 14, 2023 updated by: Sumitomo Pharma America, Inc.

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

A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.

This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

475

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brasov, Romania, 500079
        • 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
      • Bucuresti, Romania, 041914
        • Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII
      • Bucuresti, Romania, 060222
        • Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",
      • Bucuresti, Romania, 41914,
        • Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII
      • Iasi, Romania, 700282
        • Institutul de Psihiatrie Socola Iasi
      • Arkhangelsk, Russian Federation, 163530
        • State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
      • Ekaterinburg, Russian Federation, 620030
        • State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"
      • Leningrad, Russian Federation, 188357
        • Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"
      • Moscow, Russian Federation, 127083
        • State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"
      • Omsk, Russian Federation, 644070
        • Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"
      • Saint Petersburg, Russian Federation, 190121
        • Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"
      • Saint Petersburg, Russian Federation, 192019
        • 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, 195176
        • Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"
      • Saint Petersburg, Russian Federation, 199106
        • Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"
      • Smolensk, Russian Federation, 214031
        • 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
      • St-Petersburg, Russian Federation, 190121
        • S St-Petersburg state budget institution Psychoneurological dispensary #10
      • Stavropol, Russian Federation, 357034
        • State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"
      • Tomsk, Russian Federation, 634014
        • LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences"
      • Yaroslavl, Russian Federation, 150003
        • State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"
      • Ivano-Frankivsk, Ukraine, 76011
        • Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8
      • Kharkiv, Ukraine, 61068
        • 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
      • Kyiv, Ukraine, 03049
        • Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic
      • Smila, Ukraine, 20708
        • Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
      • Ternopil, Ukraine, 46027
        • 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
      • Uzhgorod, Ukraine, 88000
        • Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry
    • California
      • Cerritos, California, United States, 90703
        • Synexus Clinical Research US, Inc.
      • Oakland, California, United States, 94607
        • Pacific Research Partners
      • Oceanside, California, United States, 92056
        • Excell Research
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience Network
    • Florida
      • Miami, Florida, United States, 33122
        • Premier Clinical Research Institute
      • Miami Lakes, Florida, United States, 33016
        • Innovative Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research US
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Lincolnwood, Illinois, United States, 60712
        • Pillar Clinical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Louisiana Clinical Research
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • PsychCare Consultants Research
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Dean-Yurie, Altea Research
    • New York
      • Cedarhurst, New York, United States, 11516
        • Krzsztof Wroblewi-Neurobehavioral Research Inc.
      • Jamaica, New York, United States, 11432
        • Tyne Moeller-Synexus Clinical Research US Inc.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Dr. Shishuka Malhorta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEP363856
SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule
SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
Active Comparator: quetiapine XR
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Other Names:
  • Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
Time Frame: 52 Weeks
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Actual)

December 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 2, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

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 Center for Global Clinical Data Research 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on SEP363856

Subscribe