NCT01177306已完成4 期
Phase 4 Study of the Effect of Extended Release Guanfacine on Working Memory in Children With ADHD
Lori A. Schweickert, MD1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2010年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Central Nervous System-Vital Signs (CNS-VS)
研究概览
简要总结
Minimum 24 subjects aged 8-12 with a diagnosis of ADHD will be prescribed extended release guanfacine (Intuniv) to assess impact, if any, on working memory. Pre and post testing using a standardized battery of tests for effect on symptoms of ADHD and working memory will be administered and assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline
- •2 Outpatient status
- •Age 8-12 (inclusive) at baseline
- •Males or Pre-menarchal females
- •English-speaking parent and subject
- •If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
- •Intellectual capacity to provide assent, as deemed by the Principal Investigator
- •No known cardiac history, including bradycardia, heart block, syncope or tachycardia
- •No known history of hypotension or hypotension at baseline
- •Willing to provide informed consent/ assent per IRB protocol
排除标准
- •• 1.Meet DSM-IV criteria for ADHD, combined, inattentive, or hyperactive/impulsive subtype, as evidenced by minimum score of 24 on the ADHD-RS-IV at baseline
- •2 Outpatient status
- •Age 8-12 (inclusive) at baseline
- •Males or Pre-menarchal females
- •English-speaking parent and subject
- •If on stimulant medication, has demonstrated sub-optimal response to treatment ad is willing to be washed out (discontinued) from stimulant
- •Intellectual capacity to provide assent, as deemed by the Principal Investigator
- •No known cardiac history, including bradycardia, heart block, syncope or or tachycardia
- •No known history of hypotension or hypotension at baseline
- •Willing to provide informed consent/ assent per IRB protocol
- •No history of hepatic or renal impairment
研究组 & 干预措施
Extended Release Guanfacine
Experimental
pre and post testing of working memory in subjects whose ADHD has responded to extended release guanfacine. Subjects will be tested before starting study drug and after 6-8 weeks on a stable dose of the study drug.
干预措施: extended release guanfacine (Drug)
结局指标
主要结局
Central Nervous System-Vital Signs (CNS-VS)
时间窗: 6-8 weeks on stable dose of study drug
standardized computer administered battery
次要结局
- Wide Range Assessment of Memory and Learning(WRAML)(6-8 weeks on stable dose of study drug)
研究者
Lori A. Schweickert, MD
MD
Schweickert, Lori A., M.D.
研究点 (1)
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