Long-Duration Stimulant Treatment of ADHD in Young Children-Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions-Severity (CGI-S)
研究概览
简要总结
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
详细描述
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.
Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents/guardians and children must speak English and/or Spanish; parents/guardians must sign consent form; children must verbally assent.
- •Boys and girls from 4-5 years old (inclusive) at screening.
- •Children who meet the DSM-IV criteria for a primary diagnosis of ADHD (combined or hyperactive subtype), with symptoms present for at least 9 months.
- •Children who demonstrate adequate need for treatment due to ADHD symptom-severity and clinical impairment.
- •Children with IQ of at least 70 confirmed by valid IQ test.
- •Children who are in educational settings (pre-school, kindergarten, or elementary school program) with at least 8 same-age peers for at least two half days weekly.
- •Parents and children who can attend weekly study visits.
- •Children who are naïve to ADHD medications; received ADHD medications in the past but are not currently treated; or on ADHD medications but finding them inconvenient (due to short duration of action) or not very helpful
排除标准
- •Children and parents/guardians who do not understand or cannot follow necessary instructions; children and parents who are unwilling to comply with study procedures or cooperate with child psychiatrist.
- •Children taking excluded medications.
- •Children with history of intolerance to MPH/stimulant medications or no response to adequate stimulant trials.
- •Children with current adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or other psychiatric disorders.
- •Children with history of physical, sexual, or emotional abuse, which lead to a significant impact on the clinical presentation and potentially some ADHD symptoms.
- •Children with screening abnormalities deemed clinically significant by child psychiatrist.
研究组 & 干预措施
ADHD Treatment Group
Single-arm, open-label, once-daily-dosing of long-duration beaded MPH (B-MPH) at 10-30 mg (flexible titration) in 4-to-5 year old children with ADHD.
干预措施: B-MPH (Drug)
结局指标
主要结局
Clinical Global Impressions-Severity (CGI-S)
时间窗: week 5
CGI-S is designed to assess severity of illness on a seven-point scale: 1 = normal (not at ll ill) to 7 = among the most extremely ill patients. Range: 0-7, higher score means worse outcome. Change from baseline is reported.
Children's Global Assessment Scale (C-GAS)
时间窗: week 5
Children's Global Assessment Scale (C-GAS) is designed to assess overall functioning across settings. The scale is rated from 1 to 100, with lower scores reflecting poorer adjustment. Change from baseline is reported.
Swanson, Nolan, and Pelham Questionnaire (SNAP-IV)
时间窗: week 5
The SNAP-IV Rating Scale is a revision of the Swanson, Nolan and Pelham (SNAP) Questionnaire (Swanson et al, 1983). The SNAP-IV is based on a 0 to 3 rating scale: Not at All = 0, Just A Little = 1, Quite A Bit = 2, and Very Much = 3. Subscale scores on the SNAP-IV are calculated by summing the scores on the items in the subset and dividing by the number of items in the subset. The score for any subset is expressed as the Average Rating-Per-Item, as shown for ratings on the ADHD-Inattentive (ADHD-I) subset. Sub scale ranges from 0-3. Higher scores mean better outcome. Change score from baseline is reported.
次要结局
未报告次要终点
研究者
Laurence Greenhill
Research Psychiatrist 2
New York State Psychiatric Institute