A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with 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
- •Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-Ⅳ-TR (M.I.N.I.KID will be used as backup)
- •Male and female patients aged 13-17 years (between IC and end of dosing)
- •Patients with a PANSS score of 70 or more [both at start of dosing (Day 1 and at baseline
- •Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
- •Inpatient or outpatient status
排除标准
- •Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
- •Patients who have been compulsorily admitted to hospital
- •Patients with mental retardation
- •Patients with thyroid disorder
- •Patients who have a history of receiving treatment with clozapine, or who have received sufficient doses of two or more kinds of antipsychotic drug for more than four weeks but failed to respond to this treatment
- •Patients who have received a prohibited concomitant medication or therapy listed in table 6.4-1 after the start of the prohibited concomitant medication timeframe [to be confirmed at start of dosing (Day 1) and at baseline].
- •Patients who have a history of receiving treatment with aripiprazole
- •Patients who fall under a contraindication listed in the ABILIFY package insert
- •Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
- •Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
- •Patients with diabetes. and patients who fall under any of the following:
- •fasting blood glucose level ≧126 mg/ｄL, non-fasting blood glucose level ≧200 mg/dL, HbA1c≧6.5%
- •Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
- •Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
- •Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
- •Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
- •Patients with a history or a complication of water intoxication
- •Patients with Parkinson's disease
- •Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception and have a negative pregnancy test result are eligible for inclusion in this study.
- •Patients who have a diagnosis of a substance-related disorder according to DSM-Ⅳ-TR within the past 3 months
- •Patients with a positive drug screen (urine) result
- •Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator
研究组 & 干预措施
Low (2 mg/day)
Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
干预措施: Aripiprazole Low (2 mg/day) (Drug)
Mid (6 - 12 mg/day)
Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
干预措施: Aripiprazole Mid (6 - 12 mg/day) (Drug)
High (24 - 30 mg/day)
Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
干预措施: Aripiprazole High (24 - 30 mg/day) (Drug)
结局指标
主要结局
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline (Day 1) and Day 43
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.
次要结局
- Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score(Baseline (Day 1) and day43)
- Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score(Baseline (Day 1) and Day 43)
- Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score(Baseline (Day 1) and Day 43)
- Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score(Baseline (Day 1) and Day43)