A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Description
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key 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 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms. 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of scre…
Interventions
- DrugSEP-363856
tablet
- OtherPlacebo
tablet
Locations (73)
- Pillar Clinical Research LLC - Bentonville SiteBentonville, Arkansas
- Pillar Clinical Research (Little Rock AR) SiteLittle Rock, Arkansas
- Woodland International Research Group SiteLittle Rock, Arkansas
- Woodland Research Northwest SiteRogers, Arkansas
- Clinical Innovations, Inc. dba CITrials (Bellflower)Bellflower, California
- ProScience Research Group SiteCulver City, California