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

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

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Drug: Placebo; Drug: GlyTI-M

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo Comparator: starch
ACTIVE_COMPARATOR: GlyTI-M; GlyTI-M: 0.03gm/kg/day	Drug: GlyTI-M

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Ruu-Fen Tzang, M.D., Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 8, 2012
• First Posted (ESTIMATE): November 14, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 16, 2013
• Last Update Submitted That Met QC Criteria: July 14, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: ADHD; GlyTI-M
• Other Study ID Numbers: 09MMHIS178 (OTHER: 09MMHIS178)