A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .
详细描述
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
- •Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening
- •Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
- •Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
- •Participants with a weight of equal to or greater than 29 kilogram
排除标准
- •Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
- •Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening
- •Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
- •Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit
- •Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)
研究组 & 干预措施
Paliperidone extended-release (ER)
Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
干预措施: Paliperidone extended release (ER) (Drug)
Aripiprazole
Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
时间窗: Baseline and Day 56
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
次要结局
- Change From Baseline in PANSS Total Score at Day 182(Baseline and Day 182)
- Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182(Baseline, Day 56 and Day 182)
- Change From Baseline in Other Marder Factors Scores at Day 56 and 182(Baseline, Day 56 and 182)
- Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182(Baseline, Day 56 and 182)
- Number of Participants With Clinical Stability(Day 56 and 182)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182(Baseline, Day 56 and 182)
- Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182(Baseline, Day 56 and Day 182)
- Number of Participants With PANSS Response(Day 56 and 182)