NCT00282139终止不适用
Aripiprazole in the Treatment of Tourette's Syndrome
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Global improvement in severity of symptoms (tic behaviors)
研究概览
简要总结
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
详细描述
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder;
- •"Moderate" severity as reflected on the CGI or the YGTSS;
- •Normal ECG; and,
- •Written informed consent/assent.
排除标准
- •Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence);
- •Subjects who are pregnant or nursing women;
- •Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold;
- •Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified;
- •Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months);
- •Subjects with known allergy or hypersensitivity to aripiprazole;
- •Subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication;
- •Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG, or laboratory tests; and,
- •Subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.
结局指标
主要结局
Global improvement in severity of symptoms (tic behaviors)
次要结局
- Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar DisorderBipolar DisorderManiaNCT00181779Massachusetts General Hospital20
已完成
4 期
Aripiprazole in Patients With Psychosis Associated With Parkinson's DiseasePsychosesParkinson's DiseaseNCT00095810Otsuka Pharmaceutical Development & Commercialization, Inc.50
已完成
2 期
An Open-Label Trial of Aripiprazole in Autism Spectrum DisordersAsperger's DisorderAutismPervasive Developmental DisorderNCT00308074Cambridge Health Alliance14
已完成
1 期
Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than AripiprazoleSchizophreniaNCT01552772Otsuka Pharmaceutical Development & Commercialization, Inc.60
已完成
3 期
Study of Aripiprazole in Patients With Acute Bipolar ManiaBipolar DisorderNCT00097266Otsuka Pharmaceutical Development & Commercialization, Inc.615