Long-term Effects of Medication for ADHD

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-centre open-label prospective study, enrolling 128 children and adolescents aged 6-17 years, who receive medication for ADHD of any subtype (presentation). Long-term results are evaluated with tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales; WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional Impairment Scale; WIFRS), and quality of life (Child Health and Illness Profile-Child Edition Scale; CHIP-CE) during 24 months of ADHD treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University

Criteria

Inclusion Criteria:

1. Children 6-17 years of age

2. Clinical diagnosis ADHD of any subtype and DSM 5 presentation

3. Intellectual ability in the normal range, according to Wechsler tests and clinical judgment

4. 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 Criteria:

1. Physical or psychological limitation making Qb-test unsuitable.

2. Cardiovascular disease, seizures or other unstable medical conditions that might increase the risk for the subject.

3. 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.

4. Concomitant medications (allowed at investigator's discretion), must be recorded in the subject's medical records and the CRF.

5. Substance use.