An Open-label Study of the Long Term Tolerability and Safety of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal-Alcohol Syndrome or Effects.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Pittsburg Side-Effects Scale: Stomachaches
研究概览
简要总结
Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
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 (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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 have been between the ages of 4 and 11 years at the time of entry into the double blind study.
- •Patients must meet diagnostic criteria for FASD.
- •Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any subtype. And must have an ADHDRS-IV score of > or + 90% for age and gender on either subtest or total score for children above 5 years of age.
- •Patients will continue atomoxetine/placebo until entry nto this study.
- •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 mental age (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.
排除标准
- •Have received an investigational medication other than atomoxetine in the previous 30 days.
- •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
Atomoxetine HCL (Strattera)
Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Pittsburg Side-Effects Scale: Stomachaches
时间窗: 12 months or study duration
Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Motor Tics
时间窗: 12 months or study duration
Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
时间窗: 12 months or study duration
Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
时间窗: 12 months or study duration
Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Worried/Anxious
时间窗: 12 months or study duration
Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Loss of Appetite
时间窗: 12 months or study duration
Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Dull/Tired/Listless
时间窗: 12 months or study duration
Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Headaches
时间窗: 12 months or study duration
Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Crabby/Irritable
时间窗: 12 months or study duration
Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
时间窗: 12 months or study duration
Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Socially Withdrawn
时间窗: 12 months or study duration
Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Hallucinations
时间窗: 12 months or study duration
Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Trouble Sleeping
时间窗: 12 months or study duration
Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.
次要结局
- Compare Growth While on Atomoxetine With Growth Before Entry Into Study.(12 months or study duration)
- Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.(12 months or study duration)
研究者
Laura J McGuinn, MD
Principal Investigator
University of Oklahoma