跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT00110461
NCT00110461已完成3 期

A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2005年3月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
296
试验地点
1
主要终点
Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features.

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
10 Years 至 17 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Child and adolescent patients with bipolar I disorder, manic or mixed episode with or without psychotic features

排除标准

  • •Patients with certain other psychological disorders
  • •Patients with a co-morbid serious, uncontrolled systemic illness
  • •Patients with significant risk of committing suicide

研究组 & 干预措施

1

Active Comparator

Aripiprazole 10 mg tablet

干预措施: Aripiprazole (Drug)

2

Active Comparator

Aripiprazole 30 mg tablet

干预措施: Aripiprazole (Drug)

3

Placebo Comparator

Placebo

干预措施: placebo (Drug)

结局指标

主要结局

Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 4

时间窗: Baseline and Week 4

Change from Baseline to Week 4 in Y-MRS total score, using the last observation carried forward. Assessments performed at baseline and weekly through the acute phase (Week 4). (Also performed at Weeks 6, 8, 10, 12, 16, 20, 24, and 30 through the continuation phase.) The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).

次要结局

  • Change in Young Mania Rating Scale (Y-MRS) Total Score at Week 30(Baseline and Week 30)
  • Change in Children's Global Assessment Scale (CGAS) Total Score at Week 4(Baseline and Week 4)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4(Baseline and Week 4)
  • Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 4(Baseline and Week 4)
  • Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 4(Baseline and Week 4)
  • Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 4(Baseline and Week 4)
  • Change in Children's Global Assessment (CGAS) Total Score at Week 30(Baseline and Week 30)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30(Baseline and Week 30)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4(Baseline and Week 4)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30(Baseline and Week 30)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4(Baseline and Week 4)
  • Change in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30(Baseline and Week 30)
  • Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score at Week 30(Baseline and Week 30)
  • Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Mania Score at Week 30(Baseline and Week 30)
  • Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 4(Baseline and Week 4)
  • Change in General Behavior Inventory Scale (GBI) Total Subject Version Mania Score at Week 30(Baseline and Week 30)
  • Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 4(Baseline and Week 4)
  • Change in General Behavior Inventory Scale (GBI) Total Parent/Guardian Version Depression Score at Week 30(Baseline and Week 30)
  • Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 4(Baseline and Week 4)
  • Change in General Behavior Inventory Scale (GBI) Total Subject Version Depression Score at Week 30(Baseline and Week 30)
  • Change in Attention Deficit Hyperactivity Disorders Rating Scale (ADHD-RS-IV) Total Score at Week 30(Baseline and Week 30)
  • Subject Response to Treatment at Week 4(Baseline and Week 4)
  • Subject Response to Treatment at Week 30(Baseline and Week 30)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 4(Baseline and Week 4)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Mania Score at Week 30(Baseline and Week 30)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 4(Baseline and Week 4)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Depression Score at Week 30(Baseline and Week 30)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 4(Baseline and Week 4)
  • Change From Previous Phase in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) Severity Overall Illness Score at Week 30(Baseline and Week 30)

研究者

申办方类型
Industry

研究点 (1)

Loading locations...

相似试验

已完成
3 期
Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's DisorderChronic Motor or Vocal Tic DisorderTourette's Disorder
NCT00706589Korea Otsuka Pharmaceutical Co., Ltd.61
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal WomenPostmenopauseAmenorrhea
NCT00152282Abbott105
终止
3 期
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)Sickle Cell Disease
NCT01794000Eli Lilly and Company341
已完成
3 期
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar DisorderBipolar Disorder
NCT00221416University of Cincinnati30
已完成
3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed EpisodeBipolar I Disorder
NCT00606281Otsuka Pharmaceutical Co., Ltd.258
Aripiprazole in Children and Adolescents With... | 临床试验