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

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: Schizophrenia
• Intervention / Treatment: Drug: SEP363856; Drug: quetiapine XR

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 participants with schizophrenia. This study is projected to randomize a least 300 participants 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.

Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Brasov, Romania, 500079
    • Research Site
  • Bucharest, Romania, 041914
    • Research Site
  • Bucharest, Romania, 060222
    • Research Site
  • Bucharest, Romania, 41914,
    • Research Site
  • Iași, Romania, 700282
    • Research Site
• Russia
  • Arkhangelsk, Russia, 163530
    • Research Site
  • Moscow, Russia, 127083
    • Research Site
  • Omsk, Russia, 644070
    • Research Site
  • Saint Petersburg, Russia, 188357
    • Research Site
  • Saint Petersburg, Russia, 190121
    • Research Site
  • Saint Petersburg, Russia, 192019
    • Research Site
  • Saint Petersburg, Russia, 195176
    • Research Site
  • Saint Petersburg, Russia, 199106
    • Research Site
  • Smolensk, Russia, 214031
    • Research Site
  • Stavropol, Russia, 357034
    • Research Site
  • Tomsk, Russia, 634014
    • Research Site
  • Yaroslavl, Russia, 150003
    • Research Site
  • Yekaterinburg, Russia, 620030
    • Research Site
• Ukraine
  • Ivano-Frankivsk, Ukraine, 76011
    • Research Site
  • Kharkiv, Ukraine, 61068
    • Research Site
  • Kyiv, Ukraine, 03049
    • Research Site
  • Smila, Ukraine, 20708
    • Research Site
  • Ternopil, Ukraine, 46027
    • Research Site
  • Uzhhorod, Ukraine, 88000
    • Research Site
• United States
  • California
    • Cerritos, California, United States, 90703
      • Research Site
    • Oakland, California, United States, 94607
      • Research Site
    • Oceanside, California, United States, 92056
      • Research Site
    • San Diego, California, United States, 92103
      • Research Site
    • Torrance, California, United States, 90502
      • Research Site
  • Florida
    • Miami, Florida, United States, 33122
      • Research Site
    • Miami Lakes, Florida, United States, 33016
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Research Site
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Research Site
    • Lincolnwood, Illinois, United States, 60712
      • Research Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Research Site
  • New York
    • Cedarhurst, New York, United States, 11516
      • Research Site
    • Jamaica, New York, United States, 11432
      • Research Site
    • Rochester, New York, United States, 14618
      • Research Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Research Site
  • Ohio
    • North Canton, Ohio, United States, 44720
      • Research Site

Participation Criteria

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 participant between 18 to 65 years of age (inclusive) at the time of consent.
• Participant 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 participant's diagnosis must be ≥ 1 year prior to Screening.
• Participant must have a CGI-S score ≤ 4 at Screening and Baseline.
• Participant must have a PANSS total score ≤ 80 at Screening and Baseline.
• Participant 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.
• Participant has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
• Participants 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).
• Participant 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:

• Participant was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
• Participant 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.
• Participant 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.
• Participant 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).
• Participant is at significant risk of harming self or others based on Investigator's judgment.
• Participant has attempted suicide within 6 months prior to Screening.
• Participant has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer)
• Participant 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.
• Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
• Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SEP363856; SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule	Drug: SEP363856; 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	Drug: quetiapine XR; 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	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Study Discontinuation	An AE was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Untoward medical occurrences that occured after first administration of study drug were considered AEs. A SAE is an AE that meets one or more criteria: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.	From first dose of the study drug up to 7 days after last dose of study drug (Up to 53 weeks)

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Investigators: Study Chair: CNS Medical Director, Sumitomo Pharma America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 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 (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; SEP-363856
• Other Study ID Numbers: SEP361-304; 2019-002259-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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