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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01725737
• Other study ID #: 09MMHIS178
• Secondary ID: 09MMHIS178
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2012
• Last updated: July 14, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• GlyTI-M

• Placebo
Placebo Comparator: starch

Locations

Country	Name	City	State
Taiwan	Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes