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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725737
First Posted: November 14, 2012
Last Update Posted: July 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ruu-Fen Tzang, Mackay Memorial Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Ruu-Fen Tzang, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ruu-Fen Tzang, attending physician, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT01725737     History of Changes
Other Study ID Numbers: 09MMHIS178
09MMHIS178 ( Other Identifier: 09MMHIS178 )
First Submitted: November 6, 2012
First Posted: November 14, 2012
Last Update Posted: July 16, 2013
Last Verified: July 2013

Keywords provided by Ruu-Fen Tzang, Mackay Memorial Hospital:
ADHD
GlyTI-M

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders