A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia

Study Identifier:
SEP361-121
ClinicalTrials.gov Identifier:
NCT05848700
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
  • Drug: Placebo
Date
Jun 2023 - Mar 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)
  • Male or female subject between 18 and 65 years of age (inclusive) at the time of informed 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 Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
  • 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).
  • Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.
Exclusion Criteria
  • (this list is not all inclusive)
  • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
  • Subject has attempted suicide within 6 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Item 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 Columbia Suicide Severity Rating Scale (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 significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.

Protocol Summary

A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.

Study Locations

Location
Status
Location
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Status
N/A
Location
Behavioral Clinical Research, Inc
Miami Lakes, Florida, United States, 33016
Status
N/A
Location
Research Centers of America at Fort Lauderdale Behavioral Health Center
Oakland Park, Florida, United States, 33334
Status
N/A
Location
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Status
N/A
Location
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, United States, 44720
Status
N/A
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July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • (this list is not all inclusive)
  • Male or female subject between 18 and 65 years of age (inclusive) at the time of informed 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 Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day 1.
  • 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).
  • Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.
Exclusion criteria
  • (this list is not all inclusive)
  • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
  • Subject has attempted suicide within 6 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Item 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 Columbia Suicide Severity Rating Scale (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 significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.

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