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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruu-Fen Tzang, Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01725737
First received: November 6, 2012
Last updated: July 14, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
ADHD
Drug: GlyTI-M
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial With GlyTI-M Among Children With ADHD

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Barkley's side effect rating scale [ Time Frame: 1. Change from Baseline adverse effect at 2, 4, 6 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 116
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator: starch
Active Comparator: GlyTI-M
GlyTI-M: 0.03gm/kg/day
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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725737

Locations
Taiwan
Mackay Memorial Hospital
Taipei, Taiwan, 111
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Ruu-Fen Tzang, M.D. Mackay Memorial Hospital
  More Information

No publications provided

Responsible Party: Ruu-Fen Tzang, attending physician, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01725737     History of Changes
Other Study ID Numbers: 09MMHIS178, 09MMHIS178
Study First Received: November 6, 2012
Last Updated: July 14, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Mackay Memorial Hospital:
ADHD
GlyTI-M

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014