Placebo-Controlled Trial With GlyTI-M Among Children With ADHD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)
研究概览
简要总结
Although psychostimulant is the first line of drug to treat Attention Deficit Hyperactivity Disorder, (ADHD), actually there are 10-20% ADHD patient do not response well to current medication. Most of parents of children with ADHD in Taiwan dislike to use psychostimulant. We expect that GlyTI-M will have better efficacy than placebo to reduce ADHD symptoms. This study will also help us to understand the mechanism of ADHD and give a way to develop new drug and also a more possible way to treat ADHD children under 6 years old.
详细描述
The accumulated neuro-image, hereditary and animal studies showed the correlation between glutamate transport dysfunction and ADHD psychopathology. However, there is limited clinical trial to testify the effect of modulating the NMDA receptor function of glutamate to treat ADHD.
GlyTI-M is an endogenous Glycine transporter I inhibitor, and it acts on the glutamatergic synapse to modulate the neurotransmission of N-Methyl-D-Aspertate (NMDA) receptor. This study aims to explore the effect of GlyTI-M among children with ADHD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill the criteria of ADHD according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
- •Subjects and parents agree to participate in the study and provide informed consent.
排除标准
- •Autism, Mental retardation.
- •inability to follow protocol.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
GlyTI-M
GlyTI-M: 0.03gm/kg/day
干预措施: GlyTI-M (Drug)
结局指标
主要结局
Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)
时间窗: 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week
1. Change in inattention score of SNAP-IV-C 2. Change in hyperactivity/impulsivity score of SNAP-IV-C 3. Change in oppositional defiant disorder score of SNAP-IV-C
次要结局
- Barkley's side effect rating scale(1. Change from Baseline adverse effect at 2, 4, 6 weeks)
研究者
Ruu-Fen Tzang
attending physician
Mackay Memorial Hospital