Schizophrenia
Conditions
Keywords
Schizophrenia, NBI-1117568
Brief 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.
Interventions
DRUGNBI-1117568
Oral capsules
DRUGPlacebo
Oral capsules
Sponsors
Neurocrine Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The initial Open-label Stabilization Period is open-label and non-randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From Randomization to Relapse | Up to approximately 30 weeks |
Countries
United States
Contacts
CONTACTNeurocrine Medical Information Call Center
STUDY_DIRECTORClinical Development Lead
Neurocrine Biosciences
Outcome results
None listed