Actively Recruiting

Phase 3
Age: 18Years - 65Years
All Genders
NCT07227818

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

Led by Neurocrine Biosciences · Updated on 2026-04-15

560

Participants Needed

17

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have a primary diagnosis of schizophrenia based on DSM-5-TR criteria
  • Diagnosis of schizophrenia must have been made at least 1 year before screening
  • Participants must have had a positive response to at least one antipsychotic therapy (excluding clozapine) at a therapeutic dose
Not Eligible

You will not qualify if you...

  • Participants with unstable or poorly controlled medical conditions or chronic diseases within 30 days before Day 1
  • Participants with laboratory abnormalities indicating significant unmanaged or undiagnosed disease
  • Participants with a history of clozapine treatment for treatment-resistant psychosis
  • Participants with psychiatric inpatient stays of 30 or more consecutive days in the 90 days before screening (except for social reasons or other clinical trial participation)
  • Participants who started or increased nonpharmacological psychosocial therapy within 3 weeks before screening or expect changes during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Neurocrine Clinical Site

Garden Grove, California, United States, 92845

Actively Recruiting

2

Neurocrine Clinical Site

La Habra, California, United States, 90631

Actively Recruiting

3

Neurocrine Clinical Site

Lemon Grove, California, United States, 91945

Actively Recruiting

4

Neurocrine Clinical Site

Oceanside, California, United States, 92056

Actively Recruiting

5

Neurocrine Clinical Site

West Hills, California, United States, 91307

Actively Recruiting

6

Neurocrine Clinical Site

Hollywood, Florida, United States, 33024

Actively Recruiting

7

Neurocrine Clinical Site

Maitland, Florida, United States, 32751

Actively Recruiting

8

Neurocrine Clinical Site

Miami, Florida, United States, 33122

Actively Recruiting

9

Neurocrine Clinical Site

Tampa, Florida, United States, 33629

Actively Recruiting

10

Neurocrine Clinical Site

West Palm Beach, Florida, United States, 33024

Actively Recruiting

11

Neurocrine Clinical Site

Atlanta, Georgia, United States, 30318

Actively Recruiting

12

Neurocrine Clinical Site

Boston, Massachusetts, United States, 02116

Actively Recruiting

13

Neurocrine Clinical Site

Flowood, Mississippi, United States, 39232

Actively Recruiting

14

Neurocrine Clinical Site

Cedarhurst, New York, United States, 11516

Actively Recruiting

15

Neurocrine Clinical Site

New York, New York, United States, 10029

Actively Recruiting

16

Neurocrine Clinical Site

New York, New York, United States, 10036

Actively Recruiting

17

Neurocrine Clinical Site

Bellevue, Washington, United States, 98007

Actively Recruiting

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Research Team

N

Neurocrine Medical Information Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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