RightFit
RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NBI-1117568 delays the return of schizophrenia symptoms compared with a placebo (a pill with no active drug). It is for adults whose symptoms have a stable response after taking NBI-1117568 in an earlier part of the study.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia confirmed by a full mental health exam using standard diagnosis rules.
  • Were first diagnosed with schizophrenia at least 1 year before screening.
  • Have improved with at least one medicine for psychosis, other than clozapine, at a dose used for treatment.

Who can't join

  • Have an unstable or poorly controlled illness that may affect the study, or cancer, within 30 days before Day 1.
  • Have lab results that suggest a serious disease that is poorly managed or has not been diagnosed or managed.
  • Have taken clozapine for psychosis that did not respond to other treatments.
  • Stayed in a mental health hospital for at least 30 days in a row during the 90 days before screening. Stays only for social reasons or another clinical trial do not count.
  • Started or increased non-medicine treatment, such as therapy or social support treatment, within 3 weeks before screening, or expect it to change during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (22)

CA

FL

GA

MA

MS

NJ

NY

TX

WA