A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
详细描述
This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in adolescent subjects (ages 13-17) with a DSM-5 diagnosis 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
- •PANSS score >= 80, inclusive, at screening and baseline
排除标准
- •Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening.
- •Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia or other cognitive disorders
- •Subjects who have been hospitalized > 21 days for a current exacerbation of schizophrenia at the time of baseline.
- •Any neurological disorder other than Tourette's Syndrome
- •Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
- •Subjects with epilepsy, a history of seizures, severe head trauma or stroke
- •Subjects who test positive for drugs of abuse at screening
研究组 & 干预措施
Brexpiprazole
Participants were administered with brexpiprazole oral tablets, daily, dose titrated up to 0.5 mg by Day 4, 1 mg by Day 7, 2 mg by Day 14, then between 2-4 mg after Day 21 up to Week 6 with a 1 mg increase or decrease, based on the Investigator's decision.
干预措施: Brexpiprazole (OPC-34712) (Drug)
Aripiprazole
Participants were administered with aripiprazole oral tablets, daily, dose titrated up to 2 mg by Day 4, 5 mg by Day 7, 10 mg by Day 14, then 10, 15 or 20 mg after Day 21 up to Week 6 with a 5 mg increase or decrease, based on the Investigator's decision.
干预措施: Aripiprazole (Drug)
Placebo
Participants were administered with brexpiprazole or aripiprazole matching placebo oral tablets, daily up to Week 6.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline to Week 6
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) to 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranges from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worsening of symptoms. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed effect of treatment, (pooled) clinical center visit, treatment visit interaction, baseline value and baseline visit interaction as a covariate, and with an unstructured covariance.
次要结局
- Mean Clinical Global Impression Improvement (CGI-I) Scale Score at Week 6(Week 6)
- Mean Change From Baseline in Body Mass Index (BMI)(Baseline up to last visit (approximately 6 weeks))
- Percentage of Participants Achieving Response(Up to 6 weeks)
- Change From Baseline to Week 6 in PANSS Positive and Negative Sub-Scales Scores(Baseline to Week 6)
- Mean Change From Baseline in Weight(Baseline up to last visit (approximately 6 weeks))
- Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Number of Participants With Severe Psychotropic Side Effects as Assessed by Udvalg for Kliniske Undersogelser (UKU) Rating Scale(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Percentage of Participants Achieving Remission(Up to 6 weeks)
- Change From Baseline to Week 6 in Clinical Global Impression Severity (CGI-S) Scale Score(Baseline to Week 6)
- Number of Participants With Adverse Events (AEs) and Trial Discontinuation Due to AEs(From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks))
- Change From Baseline in Simpson Angus Scale (SAS) Total Score(Baseline up to last visit (approximately 6 weeks))
- Number of Participants With Cognitive Adverse Effects Assessed by New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Number of Participants With Potentially Clinically Relevant Laboratory Test Values(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Change From Baseline to Week 6 in Children's Global Assessment Scale (CGAS) Total Score(Baseline to Week 6)
- Mean Change From Baseline in Waist Circumference(Baseline up to last visit (approximately 6 weeks))
- Number of Participants With At Least One Occurrence of Suicidal Behavior or Suicidal Ideation as Recorded on Columbia-Suicide Severity Rating Scale (C-SSRS)(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Number of Participants With Potentially Clinically Relevant Abnormalities in Vital Signs(From the first dose of study drug up to last dose of study drug (up to approximately 6 weeks))
- Number of Participants With Treatment-emergent AEs (TEAEs), Serious TEAEs, and TEAEs Graded by Severity(From the first dose of study drug up to 21 days after the last dose of study drug (up to approximately 9 weeks))
- Mean Change From Baseline in Height(Baseline up to last visit (approximately 6 weeks))
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score(Baseline up to last visit (approximately 6 weeks))
- Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score(Baseline up to last visit (approximately 6 weeks))