NCT04959032已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Time to first symptom relapse during the Double-blind Treatment Phase
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
详细描述
The study will be conducted in the following 5 phases:
- A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed;
- A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day;
- A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day;
- A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio);
- A 2-week Safety Follow-up (SFU) Phase.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 60 years of age, inclusive.
- •Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5).
- •Diagnosis of schizophrenia for a minimum of 1 year before Visit
- •Current psychotic episode < 4 weeks duration at Visit
- •PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit
- •Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms: delusions (P1), hallucinatory behavior (P3), conceptual disorganization (P2), suspiciousness/persecution (P6) at Visit 1 and Visit
- •Patient must identify a caregiver who provides consents to participate in the study.
- •In the opinion of the Investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study.
排除标准
- •Currently meeting DSM-5 criteria for any of the following:
- •Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study.
- •Patients in their first episode of psychosis.
- •Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).
研究组 & 干预措施
Lumateperone 42 mg
Experimental
干预措施: Lumateperone 42 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to first symptom relapse during the Double-blind Treatment Phase
时间窗: Number of days from the randomization date to the first relapse date up to 26 weeks.
次要结局
未报告次要终点
研究者
研究点 (2)
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