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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01725737

Enrollment

116

Registered

2012-11-14

Start date

2012-04-30

Completion date

2013-04-30

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, GlyTI-M

Brief summary

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

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.

Interventions

DRUGGlyTI-M

DRUGPlacebo

Placebo Comparator: starch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	1. Change in inattention score of SNAP-IV-C 2. Change in hyperactivity/impulsivity score of SNAP-IV-C 3. Change in oppositional defiant disorder score of SNAP-IV-C

Secondary

Measure	Time frame	Description
Barkley's side effect rating scale	1. Change from Baseline adverse effect at 2, 4, 6 weeks	1. Change from Baseline adverse effect at 2 weeks 2. Change from Baseline adverse effect at 4 weeks 3. Change from Baseline adverse effect at 6 weeks

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026