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

Study Identifier:
SEP361-308
ClinicalTrials.gov Identifier:
NCT05628103
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
Download document(s)
Statistical Analysis Plan
Available Language: English
Download document(s)

Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: SEP-363856
Date
Dec 2022 - Apr 2024
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • This list is not all inclusive
  • Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
  • 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
  • This list is not all inclusive
  • Participant 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.
  • 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.

Protocol Summary

This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.

Study Locations

Location
Status
Location
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Status
N/A
Location
Clinical Innovations Inc.
Bellflower, California, United States, 90706
Status
N/A
Location
ProScience Research Group
Culver City, California, United States, 90230
Status
N/A
Location
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States, 92845
Status
N/A
Location
Synergy San Diego
Lemon Grove, California, United States, 91945
Status
N/A
Location
Clinical Innovations, Inc
Riverside, California, United States, 92506
Status
N/A
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July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • This list is not all inclusive
  • Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
  • 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
  • This list is not all inclusive
  • Participant 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.
  • 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.

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