A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Study Identifier:
SEP361-302
ClinicalTrials.gov Identifier:
NCT04092686
EudraCT Identifier:
2019-000697-37
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 75mg
  • Drug: SEP-363856 100mg
  • Drug: Placebo
Date
Oct 2019 - Jun 2023
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
  • Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant must give written informed consent and privacy authorization prior to participation in the study.
  • Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
  • Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
  • Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.
  • Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  • Participant has marked deterioration of functioning in one or more areas.
  • Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
Exclusion Criteria
  • Participant has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
  • Participant is at significant risk of harming self, others, or objects 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 has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Protocol Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

Study Locations

Location
Status
Location
Research Site
Rogers, Arkansas, United States, 72758
Status
N/A
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
Culver City, California, United States, 90230
Status
N/A
Location
Research Site
Long Beach, California, United States, 90806
Status
N/A
Location
Research Site
San Diego, California, United States, 92102
Status
N/A
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July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant must give written informed consent and privacy authorization prior to participation in the study.
  • Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
  • Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
  • Participant must have a Positive and Negative Syndrome Scale (PANSS) total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content.
  • Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  • Participant has marked deterioration of functioning in one or more areas.
  • Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
Exclusion criteria
  • Participant has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
  • Participant is at significant risk of harming self, others, or objects 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 has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

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