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临床试验/NCT02039908
NCT02039908已完成4 期

Examining Tolerance to CNS Stimulants in ADHD

Florida International University1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
267
试验地点
1
主要终点
Number of Dose Changes Required Per Protocol

研究概览

简要总结

Although stimulant medication is a well-established treatment for ADHD, it is often necessary for doctors to increase the dose over time to maintain the benefits of the medication. While medication can be very effective for improving symptoms of ADHD during the first year of use, it has not been found to significantly improve the long term course of children with ADHD. For example, in large research studies, groups of children who take medication for ten years do not have consistently better academic grades than groups of children who never used medication (individual results will vary from child to child).

In order to help children with ADHD achieve the best possible outcomes, it is important for doctors to study why this happens. One possible reason is development of tolerance to the medication. Tolerance means that a drug's effects decrease when it is taken consistently over time, so that an increased dose is needed to continue showing effects. Some doctors believe that children who take stimulant medication for ADHD develop tolerance to it which would explain why benefits may not persist over time, but no research studies have been done to measure whether this occurs. This study aims to see if children show a tolerance effect to stimulant medication and whether that tolerance can be prevented by taking short breaks from the medication called medication holidays.

详细描述

This is an innovative evaluation of tolerance using an objective measure in an analog classroom. Each subject will complete the a 10-minute math test twice a day for three weeks on optimal dose or placebo, and then be crossed over to the other condition. Within-subject drug/placebo differences will be compared over the three weeks of exposure to assess tolerance in the analog setting.

When school commences, 50% of the sample will be randomized to 7-day-a-week (continuous) dosing and 50% to 5-day-a- week (weekend holidays) dosing to examine the efficacy of prescribed weekend drug holidays for combatting need for dose escalations (tolerance) during the school year.

Participants will be assessed monthly to detect deteriorating functioning. Using a standardized protocol, study physicians will increase dose for subjects in either arm who meet defined impairment thresholds. The difference between the two dosing conditions will inform regarding how best to deal with tolerance in clinical application.

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
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of attention-deficit/hyperactivity disorder
  • Full Scale IQ above 80

排除标准

  • Psychotropic medications for conditions other than ADHD
  • Active medical or psychiatric conditions that could be worsened by stimulants
  • Diagnosis of Autism or Asperger's Disorder
  • Documented intolerance fo methylphenidate or failed trial of OROS MPH

研究组 & 干预措施

Methylphenidate 7-day dosing

Active Comparator

During the school year, children in this arm will receive 7-day dosing of medication.

干预措施: Methylphenidate (Drug)

Methylphenidate 5-day dosing

Active Comparator

During the school year phase, these children will receive 5-day dosing with weekend holidays.

干预措施: Methylphenidate (Drug)

结局指标

主要结局

Number of Dose Changes Required Per Protocol

时间窗: 10 months

Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects.

次要结局

  • Endpoint Medication Dose(End of Phase 2 School Year)
  • Time to First Dose Increase(10 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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