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

Description

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

Conditions

Schizophrenia

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Bentonville

Clinical Research Site # 145, Bentonville, Arkansas, United States, 72712

Rogers

Clinical Research Site # 138, Rogers, Arkansas, United States, 72758

Riverside

Clinical Research Site # 136, Riverside, California, United States, 92506

San Diego

Clinical Research Site # 126, San Diego, California, United States, 92123

Sherman Oaks

Clinical Research Site # 130, Sherman Oaks, California, United States, 91403

Miami Lakes

Clinical Research Site # 125, Miami Lakes, Florida, United States, 33016

Peachtree Corners

Clinical Research Site # 127, Peachtree Corners, Georgia, United States, 30071

Chicago

Clinical Research Site # 121, Chicago, Illinois, United States, 60640

Gaithersburg

Clinical Research Site # 129, Gaithersburg, Maryland, United States, 20877

Canton

Clinical Research Site # 135, Canton, Ohio, United States, 44720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 1. Participant must have a PANSS total score ≥ 80, AND a PANSS item score ≥ 4, moderate or greater, for ≥ 2 of the following Positive Scale (P) items: i. Item 1 (P1; delusions) ii. Item 2 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution);
  • 2. Participant must have a CGI-S score ≥ 4.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Otsuka Pharmaceutical Development & Commercialization, Inc.,

Study Record Dates

2028-08-31