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

Completed

• Conditions: Methylphenidate Adverse Reaction

• Registration Number: NCT04006548
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2022-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan