A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
NCT ID: NCT06894212
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
522 participants
INTERVENTIONAL
2025-02-28
2026-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Placebo
Placebo
Placebo
tablet
SEP-363856 75 mg
SEP-363856 75 mg/day
SEP-363856
tablet
SEP-363856 100 mg
SEP-363856 100 mg/day
SEP-363856
tablet
Interventions
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SEP-363856
tablet
Placebo
tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Synergy San Diego Site #128
Lemon 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
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
Premier Clinical Research Institute - Site #150
Miami, Florida, United States
D & H National Research Centers NC Site #143
Miami, Florida, United States
Innovative Clinical Research, Inc. Site # 125
Miami Lakes, 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
Eastern Clinical Research Associates - Site # 156
New Orleans, Louisiana, 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
Countries
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Central Contacts
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Facility Contacts
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Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Otsuka Call Center
Role: primary
Other Identifiers
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382-201-00035
Identifier Type: -
Identifier Source: org_study_id
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