NCT01959035已完成3 期
Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly 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
- 88
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator.
- •The patient agrees to protocol-defined use of effective contraception.
排除标准
- •The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT
- •The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT
- •The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
- •The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study.
- •The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety.
- •The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Aripiprazole once-monthly
Experimental
干预措施: Aripiprazole once-monthly (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Up to 24 weeks and 4-week safety follow up
Number of treatment emergent adverse events (TEAEs).
次要结局
- Change From Baseline to Week 24 in CGI-S Score(Baseline and Week 24)
- Change From Baseline to Week 24 in SWN-S Total Score(Baseline and Week 24)
- Change From Baseline to Week 24 in QLS Total Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the TooL Total Score(Baseline and Week 24)
- Change From Baseline to Week 24 in the WoRQ Total Score(Baseline and Week 24)
- Change From Baseline to Week 24 in ASEX Total Score(Baseline and Week 24)
- Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale(Week 24)
- Change From Baseline to Week 12 in SWN-S Total Score(Baseline and Week 12)
- Change From Baseline to Week 12 in CGI-S Score(Baseline and Week 12)
- Change From Baseline to Week 12 in QLS Total Score(Baseline and Week 12)
- Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score(Baseline and Week 12)
- Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score(Baseline and Week 12)
- Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score(Baseline and Week 12)
- Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score(Baseline and Week 12)
- Change From Baseline to Week 12 in the TooL Total Score(Baseline and Week 12)
- Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale(Week 12)
- Change From Baseline to Week 12 in the WoRQ Total Score(Baseline and Week 12)
- Change From Baseline to Week 12 in ASEX Total Score(Baseline and Week 12)
研究者
研究点 (1)
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