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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 the behavioral and psychological symptoms of schizophrenia in adults. Researchers will compare NBI-1117568 to a placebo (an inactive substance that looks like the study drug). You might be able to join if you are an adult between 18 and 65 years old, have a diagnosis of schizophrenia, and are currently in the hospital due to a worsening of your symptoms. The study aims to see how much symptoms improve by Week 5, using a common rating scale called the Positive and Negative Syndrome Scale (PANSS). The recruitment status is currently unclear, and the study plans to enroll 284 participants.

Study design
This interventional study will compare NBI-11177568 to a placebo in 284 adult participants. The phase of the study is not specified.
What's involved
You would need to discontinue certain medications, including antipsychotics, before joining. You must also be willing and able to stay in an inpatient setting for the duration of the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 5.

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

NCT07105098

NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Neurocrine Biosciences
~284 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:NBI-1117568Placebo

At a glance

Recruiting sites
14 of 15 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

Explore related trials

Schizophrenia

Where it's being run

15 sites across 7 states
California3
Bulgaria3
Romania3
Serbia3
Georgia1
Ohio1
Hungary1

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
Participant has 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