Status:
COMPLETED
Long-term Effects of Medication for ADHD
Lead Sponsor:
Göteborg University
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
Single-centre open-label prospective study, enrolling 127 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with ...
Detailed Description
Single-centre open-label prospective study, including 127 subjects over a period of 2 years. Children and adolescents (6-17 years) who have been diagnosed with ADHD will be enrolled and followed durin...
Eligibility Criteria
Inclusion
- Children 6-17 years of age
- Clinical diagnosis ADHD of any subtype and DSM 5 presentation
- Intellectual ability in the normal range, according to Wechsler tests and clinical judgment
- Subjects treated with ADHD medication will have a wash-out period prior to Qb-test at baseline, of 1 week for methylphenidate or amphetamine, 2 weeks for atomoxetine
Exclusion
- Physical or psychological limitation making Qb-test unsuitable.
- Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.
- Bipolar Disorder, Conduct Disorder, Psychosis, severe autism or other severe comorbid or medical conditions that in the investigator's opinion would make study participation unsuitable.
- Concomitant medications (allowed at investigator's discretion), must be recorded in the subject's medical records and the CRF.
- Substance use.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2022
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03250013
Start Date
April 1 2014
End Date
January 30 2022
Last Update
March 14 2022
Active Locations (1)
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1
Child Neuropsychiatry Unit, Sahlgrenska University Hospital
Gothenburg, Sweden, 41118