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NBI-1117568 for Preventing Relapse in Schizophrenia

This study is looking at whether a drug called NBI-1117568 can help prevent symptoms of schizophrenia from returning (relapse) in adults. Participants will first receive NBI-1117568 openly, and if their symptoms are stable, they will then be randomly assigned to receive either NBI-1117568 or a placebo (an inactive substance). The study wants to see if NBI-1117568 can delay how long it takes for symptoms to return compared to the placebo. You might be able to join if you are between 18 and 65 years old, have been diagnosed with schizophrenia for at least one year, and meet other specific health requirements. The study plans to enroll about 560 people, but its current status is unclear.

Study design
This interventional study compares NBI-1117568 to a placebo in about 560 participants. It aims to see if NBI-1117568 can delay relapse after an initial open-label treatment phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 30 weeks to measure the time until relapse.

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

NCT07227818

Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Neurocrine Biosciences
~560 participants
Updated 2026-06-05 on ClinicalTrials.gov
What's tested:NBI-1117568Placebo

At a glance

Recruiting sites
20 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time From Randomization to Relapse
Measured over Up to approximately 30 weeks

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

20 sites across 7 states
California6
Florida6
New York4
Georgia1
Massachusetts1
Mississippi1
Washington1

Study leadership

  • Clinical Development Lead · STUDY_DIRECTOR · Neurocrine Biosciences

Who to contact

Neurocrine Medical Information Call Center
[email protected]
1-877-641-3461
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 established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria.
Participant had the initial diagnosis of schizophrenia ≥1 year before screening.
Participant has had a positive response to ≥1 antipsychotic therapy (other than clozapine) at a therapeutic dose.

Exclusion

Participant has an unstable or poorly controlled medical condition or chronic disease (including history of neurological \[including dementing illness, myasthenia gravis\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) or malignancy within 30 days before Day 1.
Participant has any laboratory abnormalities suggestive of clinically significant, poorly managed, or unmanaged undiagnosed disease.
Participant has a history of clozapine treatment for treatment-resistant psychosis.
Participant has a history of a stay in a psychiatric inpatient facility for ≥30 consecutive days (other than for purely social reasons or due to participation in a different clinical trial) during the 90 days before screening.
Participant has initiated or increased intensity of nonpharmacological psychosocial therapeutic treatment within 3 weeks before screening or is expected to change throughout the length of the study.

What this trial measures

  • Time From Randomization to RelapseUp to approximately 30 weeks