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OpenTrials
Completed

NCT Number: NCT04006548

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

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.

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Key information

Conditions

Methylphenidate Adverse Reaction

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range from 6 years old to17 years old
  • Diagnosis of ADHD.

Exclusion criteria

  • mental retardation.
  • major psychiatric disorders
  • major medical disorders.

Treatment and study plan

Primary outcomes

  1. Barkley psychostimulants side effect scale

    Time frame: 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)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.