Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia
- Registration Number
- NCT07227818
- Lead Sponsor
- Neurocrine Biosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 560
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NBI-1117568 NBI-1117568 All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive NBI-1117568 during the Double-blind Treatment Period. Placebo NBI-1117568 All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period. Placebo Placebo All participants will receive NBI-1117568 during the Open-label Stabilization Period, then will be randomized to receive placebo matching NBI-1117568 during the Double-blind Treatment Period.
- Primary Outcome Measures
Name Time Method Time From Randomization to Relapse Up to approximately 30 weeks
- Secondary Outcome Measures
Name Time Method