Status:
COMPLETED
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 p...
Detailed Description
This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (75 and 100 mg/day) versus placebo over a 6-week Treatm...
Eligibility Criteria
Inclusion
- Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
- Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
- Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.
- 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
- 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 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.
- 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 investigator.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2023
Estimated Enrollment :
464 Patients enrolled
Trial Details
Trial ID
NCT04092686
Start Date
September 30 2019
End Date
June 14 2023
Last Update
June 26 2024
Active Locations (62)
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1
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
2
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
3
Clinical Innovations, Inc.
Bellflower, California, United States, 90706
4
ProScience Research Group
Culver City, California, United States, 90230