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

Study Identifier:
SEP361-301
ClinicalTrials.gov Identifier:
NCT04072354
EudraCT Identifier:
2019-000470-36
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
Subscribe to Updates

Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: SEP-363856 50mg
  • Drug: SEP-363856 75mg
  • Drug: Placebo
Date
Sep 2019 - May 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 13 - 65 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
  • Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
  • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
  • Subject must have a CGI-S score ≥ 4
  • Subject must have a 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
  • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  • Subject has marked deterioration of functioning in one or more areas.
  • Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
Exclusion Criteria
  • Subject 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 of 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.
  • Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
  • Female subject who is pregnant or lactating
  • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the 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 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.

Study Locations

Location
Status
Location
Woodland International Research Group, LLC
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Status
N/A
Location
CITrials
Bellflower, California, United States, 90706
Status
N/A
Location
Synergy San Diego
Lemon Grove, California, United States, 91945
Status
N/A
Location
Alliance for Research
Long Beach, California, United States, 90807
Status
N/A
Location
Catalina Research Institute
Montclair, California, United States, 91763
Status
N/A
Go to page
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
  • Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
  • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
  • Subject must have a CGI-S score ≥ 4
  • Subject must have a 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
  • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
  • Subject has marked deterioration of functioning in one or more areas.
  • Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
Exclusion criteria
  • Subject 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 of 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.
  • Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
  • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
  • Female subject who is pregnant or lactating
  • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

We defy limitation,

so that others can too.

Follow Us
OAPI and OPDC Locations

508 Carnegie Center Dr,

Princeton, NJ 08540, United States

Phone 609-524-6788

2440 Research Blvd,

Rockville, MD 20850, United States

Phone 301-424-9055

3956 Point Eden Way

Hayward, CA 94545, United States

Phone 800-562-3974