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

Studying SEP-363856's effects on schizophrenia symptoms and safety.

Recruiting
18-65 years
All
Phase 3

This study tests a new medicine, SEP-363856, for treating schizophrenia, a mental illness causing hallucinations and delusions (seeing or hearing things that aren’t there and having strong false beliefs). The trial will compare this medicine to a placebo, which is a fake treatment with no medicine in it. It's called "double-blind," meaning neither the doctors nor the patients know who gets the real medicine or the placebo.

Participants must be 18 to 65 years old and have had a recent flare-up of symptoms, requiring hospital care. They should also have a high score on the PANSS test, which measures the severity of schizophrenia symptoms. People with other serious mental health disorders or substance use issues are not eligible.

  • The study will take place across multiple locations.
  • Participants will receive either the study medicine or a placebo.
  • Participants may need to visit the study site multiple times.

Participants should use two types of birth control or remain abstinent. This study checks if SEP-363856 can help people with severe schizophrenia symptoms. There are risks, such as side effects from the medication, and not all participants will receive the active drug.

Study details
    Schizophrenia

NCT06894212

Otsuka Pharmaceutical Development & Commercialization, Inc.

24 May 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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