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

Neurocrine Biosciences

Summary

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.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed 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…

Locations (25)

Neurocrine Clinical Site
Garden Grove, California
Neurocrine Clinical Site
La Habra, California
Neurocrine Clinical Site
Lemon Grove, California
Neurocrine Clinical Site
Oceanside, California
Neurocrine Clinical Site
Torrance, California
Neurocrine Clinical Site
West Hills, California

Summary

Eligibility

Interventions

Locations (25)