Clinical trial NCT06894212: A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 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

Primary outcomes:
measure: The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Pillar Clinical Research LLC - Bentonville Site # 145
state: Arkansas
city: Little Rock
country: United States
facility: Pillar Clinical Research (Little Rock AR) Site #153
state: Arkansas
city: Little Rock
country: United States
facility: Woodland International Research Group Site #141
state: Arkansas
city: Rogers
country: United States
facility: Woodland Research Northwest Site # 138
state: Arkansas
city: Bellflower
country: United States
facility: Clinical Innovations, Inc. dba CITrials (Bellflower) Site #131
state: California
city: Culver City
country: United States
facility: ProScience Research Group Site #134
state: California
city: Garden Grove
country: United States
facility: CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site #123
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego Site #128
state: California
city: Montclair
country: United States
facility: Catalina Research Institute Site #142
state: California
city: Riverside
country: United States
facility: Clinical Innovations Inc. DBA CITrials (Riverside) Site #151
state: California
city: Riverside
country: United States
facility: Richmond Behavioral Associates LLC Site # 136
state: California
city: San Diego
country: United States
facility: CNRI - San Diego LLC Site # 126
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute Site # 130
state: California
city: Torrance
country: United States
facility: CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) Site #149
state: California
city: Torrance
country: United States
facility: CenExel CNS - Lost Alamitos (Collaborative Neuroscience Research) Site #149
state: California
city: Hialeah
country: United States
facility: Galiz Research Site #146
state: Florida
city: Hollywood
country: United States
facility: Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site #147
state: Florida
city: Hollywood
country: United States
facility: Cenexel RCA (Research Centers of America) Site #124
state: Florida
city: Miami Lakes
country: United States
facility: Innovative Clinical Research, Inc. Site # 125
state: Florida
city: Miami
country: United States
facility: D & H National Research Centers NC Site #143
state: Florida
city: West Palm Beach
country: United States
facility: Health Synergy Clinical Research LLC Site #140
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US Inc - Atlanta Site #148
state: Georgia
city: Atlanta
country: United States
facility: CenExel ACMR (Atlanta Center for Medical Research, LLC) Site #122
state: Georgia
city: Decatur
country: United States
facility: CenExel IRA (CenExcel iResearch, LLC) Site #132
state: Georgia
city: Peachtree Corners
country: United States
facility: Accelerated Clinical Trials in Peachtree Corners GA Site # 127
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute Site # 121
state: Illinois
city: Chicago
country: United States
facility: Pillar Clinical Research LLC (Chicago) Site #144
state: Illinois
city: Gaithersburg
country: United States
facility: Cenexel CBH (CBH Health) Site # 129
state: Maryland
city: Marlton
country: United States
facility: Hassman Research Institute, LLC Site #120
state: New Jersey
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research Site # 135
state: Ohio
city: Austin
country: United States
facility: Community Clinical Research Inc Site # 133
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research Site #152
state: Texas
city: Houston
country: United States
facility: HD Research - Memorial Hermann Surgery Center Memorial Village Site #137
state: Texas
city: Richardson
country: United States
facility: Pillar Clinical Research LLC (Richardson, TX) Site #155
state: Texas
Study officials:
References: