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To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder(ADHD) Through Pharmacogenetics.

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04006548
Collaborator
(none)
110
Enrollment
1
Location
31.1
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

We plan to recruit 200 children and adolescents aged between 6 to 17 years old in two years. Those patients would receive clinical interview by child psychiatrists to diagnose as ADHD and to exclude mental retardation, major psychiatric disorders and medical disorders. Moreover, we excluded children who ever received ADHD medication treatment more than one year, or received medication in recent 30 days. Initial assessment includes collecting saliva sample, and complete questionnaires (SNAP-IV), clinical rating (CGI-S) and psychological test (CPT-II, WISC-IV, CANTAB). After 1 month methylphenidate treatment, we would evaluate SNAP-IV, CGI-S, CGI-I and Barkley Psychostimulants Side Effects Rating Scale. We also would collect saliva samples to perform appetite related gene phenotyping to see the association between medication side effect and polymorphism of appetite related genes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    To Explore the Influence of Appetite Reduction and Medication Effect of Methylphenidate in Patients With Attention-deficit/Hyperactivity Disorder Through Pharmacogenetics.
    Actual Study Start Date :
    Jul 1, 2019
    Actual Primary Completion Date :
    Feb 1, 2022
    Actual Study Completion Date :
    Feb 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Barkley psychostimulants side effect scale [One month methylphenidate use]

      This scale included 17 most common side-effects of methylphenidate. The occurrence of each side-effect was rated on a Likert scale ranging from 0 (not a problem) to 9 (severe).

    2. Clinical Global Impression scale-Improvement (CGI-I) [One month methylphenidate use]

      This scale was used to evaluate the improvement after medication treatment. It's a Likert scale range from 1 (very much improved) through to 7 (very much worse).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age range from 6 years old to17 years old

    • Diagnosis of ADHD.

    Exclusion Criteria:

    • mental retardation.

    • major psychiatric disorders

    • major medical disorders.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT04006548
    Other Study ID Numbers:
    • CGMH-IRB-201900009B0
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Attention Deficit Disorder with Hyperactivity

    Study Results

    No Results Posted as of Feb 18, 2022