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New schizophrenia drug shows promise in safety extension trial

NCT ID NCT05741528

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety of a new drug called SEP-363856 for people with schizophrenia who switched from their usual antipsychotic medication. 75 participants who completed a prior study were followed for up to 25 weeks. The main goal was to track any side effects or serious health issues. This is a disease control study because schizophrenia requires ongoing management.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

75 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: (list is not all inclusive) * Subject has given written informed consent and privacy authorization prior to participation in the study. * Subject has completed the Treatment Period of Study SEP361-308. * Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308. * Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308. Exclusion Criteria: (list is not all inclusive) * Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308. * Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308. * Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308. * Female subject is pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Bellflower, California, 90706, United States

  • Research Site

    Garden Grove, California, 92845, United States

  • Research Site

    Lemon Grove, California, 91945, United States

  • Research Site

    Santee, California, 92071, United States

  • Research Site

    Torrance, California, 90502, United States

  • Research Site

    Hollywood, Florida, 33021, United States

  • Research Site

    Miami, Florida, 33122, United States

  • Research Site

    Atlanta, Georgia, 30318, United States

  • Research Site

    Atlanta, Georgia, 30331, United States

  • Research Site

    Chicago, Illinois, 60640, United States

  • Research Site

    Gaithersburg, Maryland, 20877, United States

  • Research Site

    Berlin, New Jersey, 08009, United States

  • Research Site

    Charlotte, North Carolina, 28211, United States

  • Research Site

    Hickory, North Carolina, 28601, United States

  • Research Site

    Richardson, Texas, 75080, United States

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