Atomoxetine Pilot Study in Preschool Children With ADHD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child.
研究概览
简要总结
The purpose of this study is to determine if atomoxetine (a common brand name is Strattera), a medicine that is used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has given permission to study this drug in this age group.
详细描述
Prevalence of Attention Deficit Hyperactivity Disorder ADHD in school age children is estimated to be 2% to 11%. Many preschool age children have problems with hyperactivity, short attention span, impulsivity and other behavior dyscontrol and are quite likely to continue to have difficulties in elementary school years. Many of these children are referred for diagnosis and management of their difficult behavior and are diagnosed with ADHD. Children with ADHD often display disruptive behaviors that interfere with their functioning at school, home and in the community due to symptoms of hyperactivity, impulsiveness and inattention.
Symptoms of ADHD may be underdiagnosed and undertreated in preschool children. Preschool children with ADHD often require vigilant monitoring and supervision to ensure their safety. Symptoms of impulsivity, hyperactivity and distractibility often limit the effectiveness of educational and behavioral interventions. Hence, it is important to treat the symptoms of ADHD in children at an early age. Early intervention in children with ADHD may have an impact in the course of illness by abating longer-term disability in vulnerable children.
Pharmacological agents are considered a standard treatment recommendation in children with ADHD. Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported to be effective and safe in school-age children with ADHD. Data are not available for the usefulness of ATMX in children younger than 6 years. However, parents of younger children with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since they do not want their child taking stimulants.
There is a need to carry out treatment trials with ATMX in preschool children with ADHD in order to collect data on how effective the drug is, its safety, and the best doses to administer to children with ADHD. Therefore, this study will be a pilot project to obtain preliminary data that will then be used to help set up a larger study that will examine preschool children with ADHD.
All subjects will be screened for eligibility inclusion and exclusion criteria. Since other therapies including behavior therapy are routinely indicated, for ethical reasons subjects will continue to receive all concurrent therapies throughout the study period. All concurrent therapies will be stabilized for a minimum period of 2 weeks prior to the child's entry into the drug phase of the study. At each medication follow-up visit, a detailed history will be obtained and recorded for all concurrent treatments.
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
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child must be 36-69 months old at the time of screening to insure that the child can complete the short-term safety and efficacy trial before the age of 6 years.
- •Child must have categorical and dimensional evidence of clinically significant ADHD symptoms in multiple settings that have been present for at least six months.
- •ADHD symptoms must cause significant functional impairment in the child. Child must meet impairment scale threshold based on Children's Global Assessment Scale (C-GAS, Shaffer, Gould, Brasic et al., 1983) score <
- •Child must have resided with primary caretaker for at least 6 months prior to the screening.
- •Child's heart rate must be within the 98th percentile and blood pressure within the 95th percentile by age and gender and oral temperature values within the normal range.
排除标准
- •Child with prior failed treatment with an adequate trial of ATMX (defined by a minimum of 1.8 mg/kg/day for 4 weeks) or known hypersensitivity to ATMX. Prior failure on stimulants or other psychotropics will not be the sole reason for exclusion.
- •Child is taking MAOI or there have been less than 2 weeks since it was discontinued.
- •Concurrent treatment with other medications that have CNS effects or that affect performance (e.g., antidepressants, antipsychotics, alpha-agonists, adrenergic blockers, lithium carbonate, sedating antihistamines, decongestant or sympathomimetics). Child should be off of previous psychotropic medications for a minimum duration of one week for stimulants, clonidine or guanfacine; two weeks for bupropion, tricyclic antidepressants, venlafaxine, SSRIs (except fluoxetine and citalopram), valproate; and three weeks for fluoxetine, citalopram, and neuroleptics.
- •Child has narrow angle glaucoma.
- •Child who has a major medical condition that would interfere with involvement in the study or would be affected negatively by ATMX (i.e., heart disease, high blood pressure, glaucoma, untreated or unstable hyperthyroidism, uncontrolled seizure disorder, or illnesses that would require hospitalization).
- •Child with co-morbid psychiatric diagnoses of Major Depression, Bipolar Disorder, a psychotic disorder, or other psychiatric disorders in addition to ADHD that requires concurrent treatment with additional/alternative medication.
- •Current history of physical, sexual, or emotional abuse.
- •The patient has taken an investigational drug within the last 30 days.
结局指标
主要结局
A reduction of 30% in the Hyperactive-Impulsive (HI) subscale scores of the Conners Rating Scale-Revised, which indicates an improvement in both efficacy and a significant clinical improvement in the child.
时间窗: 7 to 13 weeks
次要结局
- Decrease in ADHD specific symptom severity and impairment(7 to 13 weeks)