NCT07227818From ClinicalTrials.govRecruiting

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

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy of NBI-1117568 in Preventing Relapse of the Symptoms of Schizophrenia and to Assess the Safety and Tolerability of NBI-1117568 in Adults With Schizophrenia

Schizophrenia

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Neurocrine Biosciences
Enrolment target: 560
Started: 16 December 2025
Main results due: July 2029
Study sites: 25
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

What this study is about

In the sponsor’s own words, from the registry.

The main objective of the study is to evaluate NBI-1117568 compared with placebo in delaying relapse of symptoms of schizophrenia in adults who have a stable response after open-label treatment with NBI-1117568.

Study sites(25)

Neurocrine Clinical Site
Garden Grove, California, United States
Recruiting
Neurocrine Clinical Site
La Habra, California, United States
Recruiting
Neurocrine Clinical Site
Lemon Grove, California, United States
Recruiting
Neurocrine Clinical Site
Oceanside, California, United States
Recruiting
Neurocrine Clinical Site
Torrance, California, United States
Recruiting
Neurocrine Clinical Site
West Hills, California, United States
Completed
Neurocrine Clinical Site
Hollywood, Florida, United States
Recruiting
Neurocrine Clinical Site
Maitland, Florida, United States
Recruiting
Neurocrine Clinical Site
Miami, Florida, United States
Recruiting
Neurocrine Clinical Site
Miami, Florida, United States
Recruiting
Neurocrine Clinical Site
Tampa, Florida, United States
Recruiting
Neurocrine Clinical Site
West Palm Beach, Florida, United States
Recruiting
Neurocrine Clinical Site
Atlanta, Georgia, United States
Recruiting
Neurocrine Clinical Site
Boston, Massachusetts, United States
Recruiting
Neurocrine Clinical Site
Flowood, Mississippi, United States
Recruiting
Neurocrine Clinical Site
Marlton, New Jersey, United States
Recruiting
Neurocrine Clinical Site
Cedarhurst, New York, United States
Recruiting
Neurocrine Clinical Site
New York, New York, United States
Recruiting
Neurocrine Clinical Site
New York, New York, United States
Withdrawn
Neurocrine Clinical Site
The Bronx, New York, United States
Recruiting
Neurocrine Clinical Site
DeSoto, Texas, United States
Recruiting
Neurocrine Clinical Site
Bellevue, Washington, United States
Recruiting
Neurocrine Clinical Site
San Juan, Puerto Rico
Recruiting
Neurocrine Clinical Site
Gornja Toponica, Serbia
Recruiting
Neurocrine Clinical Site
Kragujevac, Serbia
Recruiting

Showing 25 of 25 sites. 23 of the 25 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07227818. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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