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

NCT04115319 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: SEP361-3042019-002259-40
• Study Type: interventional
• Target: 305
• Locations: 4 countries
• Sites: 42

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.

Conditions

Schizophrenia

Keywords

schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

SEP363856

EXPERIMENTAL

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

Drug: SEP363856

quetiapine XR

ACTIVE COMPARATOR

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

Drug: quetiapine XR

Interventions

SEP363856 DRUG

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

SEP363856

quetiapine XR DRUG

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

Also known as: Seroquel XR

quetiapine XR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participant was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (42)

Research Site

Cerritos, California, 90703, United States

Location

Research Site

Oakland, California, 94607, United States

Location

Research Site

Oceanside, California, 92056, United States

Location

Research Site

San Diego, California, 92103, United States

Location

Research Site

Torrance, California, 90502, United States

Location

Research Site

Miami, Florida, 33122, United States

Location

Research Site

Miami Lakes, Florida, 33016, United States

Location

Research Site

Atlanta, Georgia, 30328, United States

Location

Research Site

Hoffman Estates, Illinois, 60169, United States

Location

Research Site

Lincolnwood, Illinois, 60712, United States

Location

Research Site

Shreveport, Louisiana, 71101, United States

Location

Research Site

St Louis, Missouri, 63128, United States

Location

Research Site

Las Vegas, Nevada, 89102, United States

Location

Research Site

Cedarhurst, New York, 11516, United States

Location

Research Site

Jamaica, New York, 11432, United States

Location

Research Site

Rochester, New York, 14618, United States

Location

Research Site

Charlotte, North Carolina, 28211, United States

Location

Research Site

North Canton, Ohio, 44720, United States

Location

Research Site

Brasov, 500079, Romania

Location

Research Site

Bucharest, 041914, Romania

Location

Research Site

Bucharest, 060222, Romania

Location

Research Site

Bucharest, 41914,, Romania

Location

Research Site

Iași, 700282, Romania

Location

Research Site

Arkhangelsk, 163530, Russia

Location

Research Site

Moscow, 127083, Russia

Location

Research Site

Omsk, 644070, Russia

Location

Research Site

Saint Petersburg, 188357, Russia

Location

Research Site

Saint Petersburg, 190121, Russia

Location

Research Site

Saint Petersburg, 192019, Russia

Location

Research Site

Saint Petersburg, 195176, Russia

Location

Research Site

Saint Petersburg, 199106, Russia

Location

Research Site

Smolensk, 214031, Russia

Location

Research Site

Stavropol, 357034, Russia

Location

Research Site

Tomsk, 634014, Russia

Location

Research Site

Yaroslavl, 150003, Russia

Location

Research Site

Yekaterinburg, 620030, Russia

Location

Research Site

Ivano-Frankivsk, 76011, Ukraine

Location

Research Site

Kharkiv, 61068, Ukraine

Location

Research Site

Kyiv, 03049, Ukraine

Location

Research Site

Smila, 20708, Ukraine

Location

Research Site

Ternopil, 46027, Ukraine

Location

Research Site

Uzhhorod, 88000, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Transparency
• Organization: Otsuka

smb_clinicaltranspa@otsuka-us.co,

1-800-441-6763

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-blind, Active Comparator-Controlled Study

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 21, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (18); RO (5); RU (13); UA (6)