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Completed

NCT Number: NCT01725737

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mackay Memorial Hospital

Taipei, 111, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GlyTI-M

Drug

Placebo

Drug

Placebo Comparator: starch

Primary outcomes

  1. 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

    • 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

Secondary outcomes

  1. Barkley's side effect rating scale

    Time frame: 1. Change from Baseline adverse effect at 2, 4, 6 weeks

    • Change from Baseline adverse effect at 2 weeks
    • Change from Baseline adverse effect at 4 weeks
    • Change from Baseline adverse effect at 6 weeks

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2012
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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