A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 2
- 主要终点
- Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
研究概览
简要总结
To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
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
- 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 has schizophrenia, diagnosed according to DSM-IV-TR®.
- •The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
- •The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.
- •The patient agrees to protocol-defined use of effective contraception.
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria) other than schizophrenia established as the primary diagnosis.
- •The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
- •The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
- •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 history of neuroleptic malignant syndrome.
- •The patient has or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
- •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 is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
研究组 & 干预措施
Aripiprazole and aripiprazole once-monthly
干预措施: Aripiprazole and aripiprazole once-monthly (Drug)
Paliperidone and paliperidone palmitate
干预措施: Paliperidone and paliperidone palmitate (Drug)
结局指标
主要结局
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
时间窗: Baseline, Week 28
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
次要结局
- Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28(Week 28)
- Change From Baseline to Week 28 in CGI-S Score(Baseline, Week 28)
- Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score(Baseline, Week 28)
- Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score(Baseline, Week 28)
- Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score(Baseline, Week 28)
- Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score(Baseline, Week 28)
- Change From Baseline to Week 28 in SWN-S Total Score(Baseline, Week 28)
- Change From Baseline to Week 28 in the TooL Total Score(Baseline, Week 28)