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New schizophrenia drug aims to ease severe symptoms in hospitalized patients

NCT ID NCT06963034

Symptom relief Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests an experimental drug, NBI-1117568, to see if it improves schizophrenia symptoms like hallucinations and delusions better than a placebo. About 284 adults with schizophrenia who need hospital care will take the drug or a placebo for 5 weeks. The main goal is to measure symptom changes using a standard rating scale.

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

About 284 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

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.

Key Inclusion Criteria: * Participant has a primary diagnosis of schizophrenia * Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization. * Participants taking prohibited medications, including antipsychotics, must discontinue before study participation * Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements Key Exclusion Criteria: * Participant has known hypersensitivity to any component of the formulation of NBI-1117568. * Participant has an unstable or poorly controlled medical condition or chronic disease * Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others * Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening * Participant has a positive alcohol test or drug screen for disallowed substances * Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements. Note: Other protocol-specified inclusion/exclusion criteria may apply.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Neurocrine Clinical Site

    RECRUITING

    Bryant, Arkansas, 72022, United States

  • Neurocrine Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Neurocrine Clinical Site

    RECRUITING

    Anaheim, California, 92805, United States

  • Neurocrine Clinical Site

    RECRUITING

    Pico Rivera, California, 90660, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Diego, California, 92123, United States

  • Neurocrine Clinical Site

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • Neurocrine Clinical Site

    RECRUITING

    Torrance, California, 90504, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Neurocrine Clinical Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Neurocrine Clinical Site

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Neurocrine Clinical Site

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Neurocrine Clinical Site

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Neurocrine Clinical Site

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Neurocrine Clinical Site

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Neurocrine Clinical Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Neurocrine Clinical Site

    RECRUITING

    The Bronx, New York, 10461, United States

  • Neurocrine Clinical Site

    RECRUITING

    Austin, Texas, 78754, United States

  • Neurocrine Clinical Site

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Neurocrine Clinical Site

    RECRUITING

    Houston, Texas, 77043, United States

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