NCT00417794已完成1 期
A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- ADHD Rating Scale - IV
研究概览
简要总结
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
详细描述
Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be between the ages of 4 and 11 years at the time of entry into the study.
- •Patients must meet diagnostic criteria for FASD
- •Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of > or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.
- •Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit
- •History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
- •Patients must be able to swallow capsules.
- •Patients must be of a sufficient developmental level (~3 yrs) to participate in the study.
- •Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.
- •Teacher must agree to cooperate with the study. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD.
排除标准
- •Have received an in investigational medication in the past 30 days.
- •Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.
- •Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
- •Have used MAOIs within one month prior to visit
- •Patients with hypertension.
- •Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
- •Patients taking anticonvulsants for seizure control.
- •Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit
- •Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
- •Pubertal girls.
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
Atomoxetine HCL (Strattera)
干预措施: Strattera (Drug)
结局指标
主要结局
ADHD Rating Scale - IV
时间窗: length of protocol
次要结局
- Determine if atomoxetine improves behaviors in the mornings and evenings.(Length of protocol)
- Determine if atomoxetine is safe and well tolerated by children with FAS.(length of protocol)
- Determine if atomoxetine is effective in both school and home, and significantly reduces symptoms of inattention, hyperactivity, and impulsivity in children with FAS compared to children with FAS receiving placebo.(length of protocol)
- Determine if parents of children with FAS are satisfied with the effectiveness of atomoxetine.(Length of protocol)
- Determine if there are any differences in the adverse effects profile of children with FAS compared to the overall profile for atomoxetine.(Length of protocol)
- Determine the degree of functional limitation experienced by this group of children with FAS and whether this impairment is decreased by treatment with atomoxetine as demonstrated by the Pediatric Evaluation of Disability Inventory (PEDI)(Length of protocol)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
4 期
Efficacy of Atomoxetine for ADHD in Adolescents and Young Adults With SUDSubstance Use DisorderAttention Deficit Hyperactivity DisorderNCT01207622Massachusetts General Hospital
已完成
2 期
Atomoxetine and Huntington's DiseaseChoreaHuntington DiseaseNCT00368849University of Iowa20
已完成
2 期
Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)Cognitive ImpairmentParkinson's DiseaseNCT01738191Medical University of South Carolina30
已完成
4 期
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum DisorderAutistic DisorderAttention Deficit Disorder With HyperactivityNCT00380692Eli Lilly and Company97
已完成
不适用
Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal WomenCognitive DisturbancesMenopauseNCT00611533University of Pennsylvania16