NCT01810380已完成3 期
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 6 in PANSS Total Score
研究概览
简要总结
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
- •The patient is willing to be hospitalised from the Screening Visit through Week
- •The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
- •The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
- •The patient agrees to protocol-defined use of effective contraception.
排除标准
- •The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
- •The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
- •The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- •The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- •The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
- •The patient has a history of neuroleptic malignant syndrome.
- •The patient has any relevant medical history or current presence of systemic disease.
- •The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
- •The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.
- •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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Brexpiprazole
Experimental
Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability.
干预措施: Brexpiprazole (Drug)
Quetiapine extended release
Other
Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.
干预措施: Quetiapine extended release (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in PANSS Total Score
时间窗: Baseline and Week 6
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
次要结局
- CGI-I Score at Week 6(Week 6)
- Change From Baseline to Week 6 in CGI-S Score(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts(Baseline and Week 6)
- Discontinuation Due to Lack of Efficacy During the Study(Baseline to Week 6)
- Change From Baseline to Week 6 in PANSS Positive Subscale Score(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Negative Subscale Score(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Excited Component Score(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms(Baseline and Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression(Baseline and Week 6)
- Change From Baseline to Week 6 in PSP Total Score(Baseline and Week 6)
- PSP Functional Remission Rate at Week 6(Week 6)
- PSP Functional Response Rate at Week 6(Week 6)
- Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement(Baseline and Week 6)
- Response Rate at Week 6(Baseline and Week 6)
- PSP Domain D: Disturbing and Aggressive Behaviours at Week 6(Week 6)
研究者
研究点 (1)
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