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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 20
- 主要终点
- Time From Randomization to Relapse
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The initial Open-label Stabilization Period is open-label and non-randomized.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: NBI-1117568 (Drug)
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.
干预措施: NBI-1117568 (Drug)
结局指标
主要结局
Time From Randomization to Relapse
时间窗: Up to approximately 30 weeks
次要结局
未报告次要终点