NCT06894212 · Otsuka Pharmaceutical Development & Commercialization, Inc.
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
What this study is about
This is a Phase 3, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment Trial to Determine the the effectiveness and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia
View original scientific 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
Interventions
DRUG
SEP-363856
tablet
OTHER
Placebo
tablet
Primary outcome measures
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bentonville, Arkansas
- Little Rock, Arkansas
- Rogers, Arkansas
- Bellflower, California
- Culver City, California
- Garden Grove, California
- Lemon Grove, California
- Montclair, California
- Riverside, California
- San Diego, California
- Sherman Oaks, California
- Torrance, California
And 17 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations