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
NCT ID: NCT05628103
Last Updated: 2025-11-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
101 participants
INTERVENTIONAL
2022-12-19
2024-04-01
Brief Summary
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Detailed Description
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Following a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SEP-363856
Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.
SEP-363856
SEP-363856 flexibly dosed for 8 weeks.
Interventions
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SEP-363856
SEP-363856 flexibly dosed for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Participants are 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.
* Participants 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.
* Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
Exclusion Criteria
* Participants are at significant risk of harming self or others based on investigator's judgment.
* 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.
* Female participant who is pregnant or lactating.
* Participant tests positive for drugs of abuse at Screening.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Advanced Research Center, Inc.
Anaheim, California, United States
Clinical Innovations Inc.
Bellflower, California, United States
ProScience Research Group
Culver City, California, United States
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States
Synergy San Diego
Lemon Grove, California, United States
Clinical Innovations, Inc
Riverside, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
San Diego, California, United States
CMB Clinical Trials
Santee, California, United States
Cenexel CNS Research
Torrance, California, United States
Larkin Behavioral Health Services
Hollywood, Florida, United States
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Wellness Research Center
Miami, Florida, United States
Nova Psychiatry, Inc.
Orlando, Florida, United States
Advanced Discovery Research LLC
Atlanta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Behavioral Research
Atlanta, Georgia, United States
Uptown Research
Chicago, Illinois, United States
CBH Health
Gaithersburg, Maryland, United States
PsychCare Consultants Research
St Louis, Missouri, United States
IMA Clinical Research
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Clinical Trials of America, LLC
Hickory, North Carolina, United States
Charak Clinical Research Center
Garfield Heights, Ohio, United States
Pillar Clinical Research, LLC
Richardson, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SEP361-308
Identifier Type: -
Identifier Source: org_study_id