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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-04-30

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.

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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.

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Comparator: starch

GlyTI-M

GlyTI-M: 0.03gm/kg/day

Group Type ACTIVE_COMPARATOR

GlyTI-M

Intervention Type DRUG

Interventions

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GlyTI-M

Intervention Type DRUG

Placebo

Placebo Comparator: starch

Intervention Type DRUG

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.