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NBI-1117568 for Schizophrenia in Inpatient Adults

This study is testing a drug called NBI-1117568 to see if it can help improve behavioral and psychological symptoms in adults with schizophrenia. You might receive NBI-1117568 or a placebo (an inactive substance) to compare their effects. To join, you must be an adult between 18 and 65 years old with a primary diagnosis of schizophrenia, experiencing a flare-up of symptoms that requires hospitalization. You also need to be willing to stay in the hospital for the study duration. The main goal is to see how much your symptoms, measured by the Positive and Negative Syndrome Scale (PANSS), change by Week 5. The study is currently unclear on its recruitment status and plans to enroll 284 participants.

Study design
This is an interventional study comparing NBI-1117568 to a placebo. It plans to enroll 284 participants.
What's involved
You would need to discontinue certain medications, including antipsychotics, before starting. You must also be willing and able to remain in an inpatient setting for the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 5, indicating follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06963034

NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Neurocrine Biosciences
~284 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:NBI-1117568Placebo

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
Measured over Baseline, Week 5

Conditions

Schizophrenia

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Schizophrenia

Where it's being run

21 sites across 10 states
California5
Georgia3
Texas3
Arkansas2
Florida2
New York2
Illinois1
Maryland1

Study leadership

  • Clinical Development Lead · STUDY_DIRECTOR · Neurocrine Biosciences

Who to contact

Neurocrine Medical Information Call Center
[email protected]
877-641-3461
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5Baseline, Week 5