Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Placebo-Controlled Trial With GlyTI-M Among Children With ADHD|
- Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C) [ Time Frame: 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week ] [ Designated as safety issue: Yes ]
- Change in inattention score of SNAP-IV-C
- Change in hyperactivity/impulsivity score of SNAP-IV-C
- Change in oppositional defiant disorder score of SNAP-IV-C
- Barkley's side effect rating scale [ Time Frame: 1. Change from Baseline adverse effect at 2, 4, 6 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline adverse effect at 2 weeks
- Change from Baseline adverse effect at 4 weeks
- Change from Baseline adverse effect at 6 weeks
|Study Start Date:||April 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Placebo Comparator: starch
Active Comparator: GlyTI-M
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.