An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

Study Identifier:
SEP361-309
ClinicalTrials.gov Identifier:
NCT05741528
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 Available

Study Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: SEP-363856
Date
Mar 2023 - Sep 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
  • (list is not all inclusive)
  • Subject has given written informed consent and privacy authorization prior to participation in the study.
  • Subject has completed the Treatment Period of Study SEP361-308.
  • Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
  • Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
Exclusion Criteria
  • (list is not all inclusive)
  • Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
  • Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
  • Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
  • Female subject is pregnant or lactating.

Protocol Summary

An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

Study Locations

Location
Status
Location
Research Site
Anaheim, California, United States, 92805
Status
N/A
Location
Research Site
Bellflower, California, United States, 90706
Status
N/A
Location
Research Site
Garden Grove, California, United States, 92845
Status
N/A
Location
Research Site
Lemon Grove, California, United States, 91945
Status
N/A
Location
Research Site
Santee, California, United States, 92071
Status
N/A
Location
Research Site
Torrance, California, United States, 90502
Status
N/A
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • (list is not all inclusive)
  • Subject has given written informed consent and privacy authorization prior to participation in the study.
  • Subject has completed the Treatment Period of Study SEP361-308.
  • Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
  • Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
Exclusion criteria
  • (list is not all inclusive)
  • Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
  • Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
  • Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
  • Female subject is pregnant or lactating.

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