A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Study Identifier:
382-201-00035
ClinicalTrials.gov Identifier:
NCT06894212
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
844-687-8522 or [email protected]
Recruiting
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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: SEP-363856
Date
Feb 2025 - Oct 2026
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 participants between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
  • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
  • The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
  • If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
  • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
  • Participant must have a PANSS total score ≥ 80
  • AND
  • Participant must have a CGI-S score ≥ 4.
  • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
Exclusion Criteria
  • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
  • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
  • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
  • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

Protocol Summary

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Study Locations

Location
Status
Location
Pillar Clinical Research LLC - Bentonville Site
Bentonville, Arkansas, United States, 72712
Status
Active, not recruiting
Location
Pillar Clinical Research (Little Rock AR) Site
Little Rock, Arkansas, United States, 72204
Status
Recruiting
Location
Woodland International Research Group Site
Little Rock, Arkansas, United States, 72211
Status
Recruiting
Location
Woodland Research Northwest Site
Rogers, Arkansas, United States, 72758
Status
Recruiting
Location
Clinical Innovations, Inc. dba CITrials (Bellflower)
Bellflower, California, United States, 90706
Status
Recruiting
Location
ProScience Research Group Site
Culver City, California, United States, 90230
Status
Active, not recruiting
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© 2025 Otsuka America Pharmaceutical, Inc.
All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).
  • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening
  • The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
  • If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.
  • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:
  • Participant must have a PANSS total score ≥ 80
  • AND
  • Participant must have a CGI-S score ≥ 4.
  • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.
Exclusion criteria
  • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
  • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
  • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
  • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

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