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| ID | Type | Description | Link |
|---|---|---|---|
| 09MMHIS178 | Other Identifier | 09MMHIS178 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| GlyTI-M | Active Comparator | GlyTI-M: 0.03gm/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GlyTI-M | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C) |
| 1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week |
| Measure | Description | Time Frame |
|---|---|---|
| Barkley's side effect rating scale |
| 1. Change from Baseline adverse effect at 2, 4, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruu-Fen Tzang, M.D. | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Taipei | Taipei | 111 | Taiwan |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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Placebo Comparator: starch |
|