A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 765
- 试验地点
- 73
- 主要终点
- Time From Baseline to the First Symptom Relapse During the Double-blind Phase
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
详细描述
There were 3 periods (phases) in the study. The Open-label Phase lasted 20 weeks. In the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this Open-label Phase. At the end of Week 8, participants had to meet the following criteria to continue in the study.
- Positive and Negative Syndrome Scale (PANSS) total score ≤ 60 at the end of Week 8
- At least 20% decrease in PANSS total score from baseline to the end of Week 8
- Clinical Global Impressions - Severity (CGI-S) score ≤ 4 at the end of Week 8
- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 8
- Stable dose during the previous 2 weeks
- No significant tolerability issues as judged by the Investigator at the end of Week 8
At the end of the Open-label Phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria:
- PANSS total score ≤ 60 at the end of Week 20
- At least 20% decrease in PANSS total score from baseline to the end of Week 20
- CGI-S score ≤ 4 at the end of Week 20
- Score of ≤ 4 on each of the following 7 PANSS items: P1, P2, P3, P6, P7, G8, and G14 at the end of Week 20
- No significant tolerability issues as judged by the Investigator During this Double-blind Treatment Phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the Open-label Phase.
All participants entered the 4 week Safety Follow-up Phase. They received a treatment other than the investigational product at the discretion of the Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
There was no masking in the Open-Label Phase. There was masking in the Double-Blind Phase
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
- •Participants who have provided informed consent prior to any study specific procedures.
- •Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
- •Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
- •Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
- •Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
- •Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
- •Body mass index between 18 and 40 kg/m^2, inclusive.
排除标准
- •Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
- •Participants in their first episode of psychosis.
- •Treatment-resistant schizophrenia over the last 2 years.
- •Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
- •At imminent risk of injuring self or others or causing significant damage to property.
- •Suicide risk.
研究组 & 干预措施
Cariprazine - Open-label Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
干预措施: Cariprazine (Drug)
Placebo - Double-blind Treatment Phase
Participants received placebo orally once a day for 26 to 72 weeks.
干预措施: Placebo (Drug)
Cariprazine - Double-blind Treatment Phase
Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks
干预措施: Cariprazine (Drug)
结局指标
主要结局
Time From Baseline to the First Symptom Relapse During the Double-blind Phase
时间窗: Up to 34 Weeks and Bi-Weekly thereafter until Week 92
Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of \>4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion. PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported.
次要结局
未报告次要终点