A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

February 16, 2024 updated by: Sumitomo Pharma America, Inc.

An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents

A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856).

Study Type

Interventional

Enrollment (Estimated)

120

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 Contact

Study Locations

    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center, Inc.
      • Bellflower, California, United States, 90706
        • Clinical Innovations Inc.
      • Culver City, California, United States, 90230
        • Proscience Research Group
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Research, LLC
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego
      • Riverside, California, United States, 92506
        • Clinical Innovations, Inc
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
      • Santee, California, United States, 92071
        • CMB Clinical Trials
      • Torrance, California, United States, 90502
        • Cenexel CNS Research
    • Florida
      • Hollywood, Florida, United States, 33021
        • Larkin Behavioral Health Services
      • Miami, Florida, United States, 33122
        • Premier Clinical Research Institute, Inc.
      • Miami, Florida, United States, 33135
        • Wellness Research Center
      • Orlando, Florida, United States, 32803
        • Nova Psychiatry, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30318
        • Advanced Discovery Research LLC
      • Atlanta, Georgia, United States, 30358
        • Atlanta Behavioral Research
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • CBH Health
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • PsychCare Consultants Research
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hassman Research Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • New Hope Clinical Research
      • Hickory, North Carolina, United States, 28601
        • Clinical Trials of America, LLC
    • Ohio
      • Garfield Heights, Ohio, United States, 44125
        • Charak Clinical Research Center
    • Texas
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research, LLC

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: This list is not all inclusive

  • Male or female subject between 18 to 65 years of age.
  • Subject meets DSM-5 criteria for a diagnosis of schizophrenia.
  • Subject is judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
  • Subject must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
  • Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.

Exclusion Criteria:This list is not all inclusive

  • Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
  • Subject is at significant risk of harming self or others based on investigator's judgment.
  • 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.
  • Female subject who is pregnant or lactating.
  • Subject tests positive for drugs of abuse at Screening.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEP-363856
SEP-363856 flexibly dosed
SEP-363856 flexibly dosed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)
Time Frame: Up to Week 12
Up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation)
Time Frame: Up to Week 12
Up to Week 12

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)

December 19, 2022

Primary Completion (Estimated)

July 24, 2024

Study Completion (Estimated)

July 24, 2024

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 28, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SEP361-308

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 Research Data 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.

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