A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

Study Identifier:
SEP361-123
ClinicalTrials.gov Identifier:
NCT05463770
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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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: SEP-363856
Date
Aug 2022 - Aug 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
  • (this list is not all inclusive)
  • Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
  • Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
  • Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
  • Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
Exclusion Criteria
  • (this list is not all inclusive)
  • \-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
  • Subject has attempted suicide within 12 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
  • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

Protocol Summary

A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes:

  • how the body processes (uses) glucose (blood sugar)
  • how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body.

The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose.

This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.

Study Locations

Location
Status
Location
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Woodland Research Northwest, LLC
Rogers, Arkansas, United States, 72758
Status
N/A
Location
Collaborative Neuroscience Research, LLC
Long Beach, California, United States, 90806
Status
N/A
Location
Catalina Research Institute LLC
Montclair, California, United States, 91763
Status
N/A
Location
CNRI - San Diego LLC
San Diego, California, United States, 92102
Status
N/A
Location
Galiz Research
Hialeah, Florida, United States, 33016
Status
N/A
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July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • (this list is not all inclusive)
  • Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version \[SCID-CT\]).
  • Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
  • Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
  • Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.
Exclusion criteria
  • (this list is not all inclusive)
  • \-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ \< 70).
  • Subject has attempted suicide within 12 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
  • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

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