Status:
COMPLETED
The Relationship Between CES1 Genotype and Methylphenidate Response in Children With ADHD - INDICES Work Package 6
Lead Sponsor:
Mental Health Services in the Capital Region, Denmark
Collaborating Sponsors:
Copenhagen University Hospital, Denmark
Conditions:
ADHD
Eligibility:
All Genders
7-12 years
Brief Summary
This is a prospective observational study of a cohort of children diagnosed with Attention Deficit Hyperactive Disorder (ADHD) and followed with weekly assessments during the first 12 weeks of Methylp...
Detailed Description
The study has three aims: 1. Examine the effect of carboxylesterase 1 (CES1) genotype in children with ADHD on the effectiveness and adverse reactions of treatment with MPH. 2. Study predictors for t...
Eligibility Criteria
Inclusion
- MPH naïve
- recent ICD-10 diagnosis of hyperkinetic disorder (F90.0-90.9) or attention deficit disorder without hyperactivity (F98.8)
- clinical indication for treatment with IR-MPH
Exclusion
- mental retardation (ICD-F70.X or IQ \< 70)
- previous treatment with drugs metabolised by carboxylesterase 1 (CES1)
- severe comorbid psychiatric or somatic disease that resulted in contraindication for treatment with MPH
- language barriers
- lack of informed consent.
- Specific additional exclusion criteria for genetic analyses:
- Non-caucasian
- Lack of DNA
- Consanguine patients
- Variants with a minor allele frequency (MAF) above 0.05 or not in Hardy-Weinberg equilibrium
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04366609
Start Date
May 1 2012
End Date
November 1 2017
Last Update
April 29 2020
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