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

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ClinicalTrials.gov Identifier: NCT01725737
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Ruu-Fen Tzang, Mackay Memorial Hospital

November 6, 2012
November 14, 2012
July 16, 2013
April 2012
February 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01725737 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
ADHD
  • Drug: GlyTI-M
  • Drug: Placebo
    Placebo Comparator: starch
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: GlyTI-M
    GlyTI-M: 0.03gm/kg/day
    Intervention: Drug: GlyTI-M
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
120
April 2013
February 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01725737
09MMHIS178
09MMHIS178 ( Other Identifier: 09MMHIS178 )
Yes
Not Provided
Not Provided
Ruu-Fen Tzang, Mackay Memorial Hospital
Mackay Memorial Hospital
Not Provided
Principal Investigator: Ruu-Fen Tzang, M.D. Mackay Memorial Hospital
Mackay Memorial Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP