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

Primary Purpose

ADHD

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
GlyTI-M
Placebo
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, GlyTI-M

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

GlyTI-M

Arm Description

GlyTI-M: 0.03gm/kg/day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 6, 2012
Last Updated
July 14, 2013
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01725737
Brief Title
Placebo-Controlled Trial With GlyTI-M Among Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Placebo-Controlled Trial With GlyTI-M Among Children With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, GlyTI-M

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
GlyTI-M
Arm Type
Active Comparator
Arm Description
GlyTI-M: 0.03gm/kg/day
Intervention Type
Drug
Intervention Name(s)
GlyTI-M
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator: starch
Primary Outcome Measure Information:
Title
Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)
Description
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
Time Frame
1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week
Secondary Outcome Measure Information:
Title
Barkley's side effect rating scale
Description
Change from Baseline adverse effect at 2 weeks Change from Baseline adverse effect at 4 weeks Change from Baseline adverse effect at 6 weeks
Time Frame
1. Change from Baseline adverse effect at 2, 4, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruu-Fen Tzang, M.D.
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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