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

Phase 3

Recruiting

• Conditions: Schizophrenia
• Interventions: Other: Placebo; Drug: SEP-363856

• Registration Number: NCT06894212
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-25
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2028-04-06
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 522

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.

Key

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
SEP-363856 75 mg	SEP-363856	SEP-363856 75 mg/day
SEP-363856 100 mg	SEP-363856	SEP-363856 100 mg/day

Primary Outcome Measures

Name	Time	Method
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6	Baseline to Week 6	To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia.; PANSS total - 30-210 Higher score is indicative of greater symptomatology

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Severity (CGI-S)	Baseline to Week 6	Change from baseline in CGI-S score at Week 6.; CGI-S is 0-7 with higher score is indicative of greater symptomatology

Trial Locations

Locations (34)

Synergy San Diego Site #128; 🇺🇸 Lemon Grove, California, United States

Pillar Clinical Research LLC - Bentonville Site # 145; 🇺🇸 Bentonville, Arkansas, United States

Pillar Clinical Research (Little Rock AR) Site #153; 🇺🇸 Little Rock, Arkansas, United States

Woodland International Research Group Site #141; 🇺🇸 Little Rock, Arkansas, United States

Woodland Research Northwest Site # 138; 🇺🇸 Rogers, Arkansas, United States

Clinical Innovations, Inc. dba CITrials (Bellflower) Site #131; 🇺🇸 Bellflower, California, United States

ProScience Research Group Site #134; 🇺🇸 Culver City, California, United States

CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site #123; 🇺🇸 Garden Grove, California, United States

Catalina Research Institute Site #142; 🇺🇸 Montclair, California, United States

Clinical Innovations Inc. DBA CITrials (Riverside) Site #151; 🇺🇸 Riverside, California, United States

Richmond Behavioral Associates LLC Site # 136; 🇺🇸 Riverside, California, United States

CNRI - San Diego LLC Site # 126; 🇺🇸 San Diego, California, United States

Schuster Medical Research Institute Site # 130; 🇺🇸 Sherman Oaks, California, United States

CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) Site #149; 🇺🇸 Torrance, California, United States

CenExel CNS - Lost Alamitos (Collaborative Neuroscience Research) Site #149; 🇺🇸 Torrance, California, United States

Galiz Research Site #146; 🇺🇸 Hialeah, Florida, United States

Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site #147; 🇺🇸 Hollywood, Florida, United States

Cenexel RCA (Research Centers of America) Site #124; 🇺🇸 Hollywood, Florida, United States

Innovative Clinical Research, Inc. Site # 125; 🇺🇸 Miami Lakes, Florida, United States

D & H National Research Centers NC Site #143; 🇺🇸 Miami, Florida, United States

Health Synergy Clinical Research LLC Site #140; 🇺🇸 West Palm Beach, Florida, United States

Synexus Clinical Research US Inc - Atlanta Site #148; 🇺🇸 Atlanta, Georgia, United States

CenExel ACMR (Atlanta Center for Medical Research, LLC) Site #122; 🇺🇸 Atlanta, Georgia, United States

CenExel IRA (CenExcel iResearch, LLC) Site #132; 🇺🇸 Decatur, Georgia, United States

Accelerated Clinical Trials in Peachtree Corners GA Site # 127; 🇺🇸 Peachtree Corners, Georgia, United States

Uptown Research Institute Site # 121; 🇺🇸 Chicago, Illinois, United States

Pillar Clinical Research LLC (Chicago) Site #144; 🇺🇸 Chicago, Illinois, United States

Cenexel CBH (CBH Health) Site # 129; 🇺🇸 Gaithersburg, Maryland, United States

Hassman Research Institute, LLC Site #120; 🇺🇸 Marlton, New Jersey, United States

Neuro-Behavioral Clinical Research Site # 135; 🇺🇸 Canton, Ohio, United States

Community Clinical Research Inc Site # 133; 🇺🇸 Austin, Texas, United States

InSite Clinical Research Site #152; 🇺🇸 DeSoto, Texas, United States

HD Research - Memorial Hermann Surgery Center Memorial Village Site #137; 🇺🇸 Houston, Texas, United States

Pillar Clinical Research LLC (Richardson, TX) Site #155; 🇺🇸 Richardson, Texas, United States