A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Purpose
This is a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
Condition
- Schizophrenia
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 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: 1. Participant must have a PANSS total score ≥ 80 AND 2. 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
Placebo |
|
|
Experimental SEP-363856 75 mg |
SEP-363856 75 mg/day |
|
|
Experimental SEP-363856 100 mg |
SEP-363856 100 mg/day |
|
Recruiting Locations
HD Research - Memorial Hermann Surgery Center Memorial Village Site #137
Houston, Texas 77043
Houston, Texas 77043
Contact:
Otsuka Call Center
Otsuka Call Center
More Details
- Status
- Recruiting
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.