Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Placebo-Controlled Trial With GlyTI-M Among Children With ADHD

Conditions
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ADHD

Intervention / Treatment
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* Drug: GlyTI-M
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Autism, Mental retardation. inability to follow protocol.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo Comparator: starch<br>|
| Active Comparator: GlyTI-M<br>GlyTI-M: 0.03gm/kg/day | Drug: GlyTI-M<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C) | 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 | 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barkley's side effect rating scale | Change from Baseline adverse effect at 2 weeks Change from Baseline adverse effect at 4 weeks Change from Baseline adverse effect at 6 weeks | 1. Change from Baseline adverse effect at 2, 4, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, GlyTI-M