A Double-Blind, Placebo-Controlled, Randomized Withdrawal, Multicenter Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 587
- 试验地点
- 95
- 主要终点
- Time to First Relapse During Double-blind Treatment Period
研究概览
简要总结
- To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia
- To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
- •Ability to follow study instructions, complete study assessment tools with minimal assistance and no alteration to the assessment tools, and likely to complete all required visits.
- •Participant meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia as determined by Structured Clinical Interview for DSM-5 (SCID-5).
- •Positive and Negative Syndrome Scale (PANSS) total score >= 70 and <= 120 at Visit 1 and Visit 2 (Day 1).
- •Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms; P1: delusions; P2: conceptual disorganization; P3: hallucinatory behaviour; P6: suspiciousness/persecution at Visit 1 and Visit 2.
排除标准
- •Currently meeting DSM-5 criteria for any of the following:
- •Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- •Bipolar I and II disorder
- •Autism spectrum disorder, intellectual development disorder, delirium, major/minor neurocognitive disorder
- •History of meeting DSM-5 criteria for substance-related disorders (excluding caffeine-related and tobacco-related disorders) within the prior 3 months before Visit
- •Prior participation in any clinical trials involving experimental or investigational drugs within 6 months before Visit 1 or planned during the study.
- •Female Participants who are pregnant, planning to become pregnant during the course of the study, or are currently lactating.
研究组 & 干预措施
Cariprazine 4.5 mg/day (Open-label Treatment Period)
Cariprazine 1.5 mg capsules orally once daily at Week 1, titrated to 3.0 mg capsules orally once daily at Week 2 and then titrated to 4.5 mg orally once daily from Week 3 through Week 18 in the Open-label Treatment Period.
干预措施: Cariprazine (Drug)
Placebo (Double-blind Treatment Period)
Cariprazine placebo-matching capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
干预措施: Placebo (Drug)
Cariprazine 3.0 mg/day (Double-blind Treatment Period)
Cariprazine 3.0 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
干预措施: Cariprazine (Drug)
Cariprazine 4.5 mg/day (Double-blind Treatment Period)
Cariprazine 4.5 mg capsules orally once daily from Week 19 through Week 44 in Double-blind Treatment Period.
干预措施: Cariprazine (Drug)
结局指标
主要结局
Time to First Relapse During Double-blind Treatment Period
时间窗: Randomization (Week 18) to End of Treatment (Week 44)
Time to Relapse is the number of days from randomization to first relapse. Relapse is defined as any 1 of the following: * Increase in Positive and Negative Syndrome Scale(PANSS) by ≥30% for participants who had total score of ≥50 at randomization or ≥10-point increased score with total score \<50 at randomization \[PANSS=30 questions where 1=absence of symptoms to 7=extremely severe symptom;total score=30 to 210;higher score more severe symptoms\] * Increase in Clinical Global Impression-Severity (CGI-S) score by 2 or more points \[1=normal to 7=among most extremely ill\] * Score of \>4 on 1 or more of 7 PANSS items:P1-delusions,P2-conceptual disorganization,P3-hallucinatory behavior,P6-suspiciousness,P7-hostility,G8-uncooperativeness,G14-poor impulse control * Deliberate self-injury * Initiation of treatment with mood stabilizer,antidepressant,antipsychotics or benzodiazepine that exceeds specified allowance * Psychiatric hospitalization * Exacerbation of psychiatric illness
次要结局
未报告次要终点