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Evaluating NBI-1117568 for treating schizophrenia in hospitalized adults

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization

Phase 3 Interventional Neurocrine Biosciences · NCT06963034

This study is testing a new medication called NBI-1117568 to see if it can help improve symptoms of schizophrenia in adults who are currently hospitalized.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment284 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations21 sites (Bryant, Arkansas and 20 other locations)
Trial IDNCT06963034 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of NBI-1117568 compared to a placebo in improving the behavioral and psychological symptoms of schizophrenia in adults who are currently hospitalized due to an acute exacerbation or relapse of their condition. Participants must be willing to stay in an inpatient setting for the duration of the study and comply with all protocol requirements. The study will involve monitoring the effects of the medication on symptoms and overall mental health during the treatment period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with a primary diagnosis of schizophrenia who are experiencing an acute exacerbation of symptoms requiring hospitalization.

Not a fit: Patients with unstable medical conditions, severe substance use disorders, or those at imminent risk of self-harm may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of schizophrenia symptoms in hospitalized patients.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating schizophrenia with novel interventions.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Bryant, Arkansas and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.