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

NCT01725737 | Completed Phase 2 DMC

• 1 other identifier: 09MMHIS178
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; GlyTI-M

Outcome Measures

Primary Outcomes (1)

• Swanson, Nolan, and Pelham, version IV scale (SNAP-IV-C)

  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

  1. Change from Baseline in inattention, hyperactivity/impulsivity , oppositional defiant disorder score of SNAP-IV-C at 0, 2, 4, 6week

Secondary Outcomes (1)

• Barkley's side effect rating scale

  1. Change from Baseline adverse effect at 2, 4, 6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

GlyTI-M

ACTIVE COMPARATOR

GlyTI-M: 0.03gm/kg/day

Drug: GlyTI-M

Interventions

GlyTI-M DRUG

GlyTI-M

Placebo DRUG

Placebo Comparator: starch

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Autism, Mental retardation.
• inability to follow protocol.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taipei, 111, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ruu-Fen Tzang, M.D.

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 14, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

TW (1)