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

NCT ID: NCT04115319

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2022-12-30

Brief Summary

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.

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SEP363856

SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule

Group Type: EXPERIMENTAL

SEP363856

Intervention Type: DRUG

SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule

quetiapine XR

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Group Type: ACTIVE_COMPARATOR

quetiapine XR

Intervention Type: DRUG

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Interventions

SEP363856

SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule

Intervention Type: DRUG

quetiapine XR

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Intervention Type: DRUG

Other Intervention Names

Seroquel XR

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Cerritos, California, United States

Research Site

Oakland, California, United States

Research Site

Oceanside, California, United States

Research Site

San Diego, California, United States

Research Site

Torrance, California, United States

Research Site

Miami, Florida, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Atlanta, Georgia, United States

Research Site

Hoffman Estates, Illinois, United States

Research Site

Lincolnwood, Illinois, United States

Research Site

Shreveport, Louisiana, United States

Research Site

St Louis, Missouri, United States

Research Site

Las Vegas, Nevada, United States

Research Site

Cedarhurst, New York, United States

Research Site

Jamaica, New York, United States

Research Site

Rochester, New York, United States

Research Site

Charlotte, North Carolina, United States

Research Site

North Canton, Ohio, United States

Research Site

Brasov, , Romania

Research Site

Bucharest, , Romania

Research Site

Bucharest, , Romania

Research Site

Bucharest, , Romania

Research Site

Iași, , Romania

Research Site

Arkhangelsk, , Russia

Research Site

Moscow, , Russia

Research Site

Omsk, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Saint Petersburg, , Russia

Research Site

Smolensk, , Russia

Research Site

Stavropol, , Russia

Research Site

Tomsk, , Russia

Research Site

Yaroslavl, , Russia

Research Site

Yekaterinburg, , Russia

Research Site

Ivano-Frankivsk, , Ukraine

Research Site

Kharkiv, , Ukraine

Research Site

Kyiv, , Ukraine

Research Site

Smila, , Ukraine

Research Site

Ternopil, , Ukraine

Research Site

Uzhhorod, , Ukraine

Countries

United States; Romania; Russia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002259-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SEP361-304

Identifier Type: -

Identifier Source: org_study_id