Long-term Effects of Medication for ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

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 tests of ADHD symptoms (Qb-test), intellectual ability (Wechsler scales;
      WISC), adaptive functioning (Vineland scale), everyday functioning (Weiss Functional
      Impairment Scale; WFIRS), and quality of life (Child Health and Illness Profile-Child Edition
      Scale; CHIP-CE) during 24 months of ADHD treatment.
    

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 during 24 months of ADHD treatment.

      Screening assessments include medical, neurodevelopmental and psychiatric history, clinical
      evaluation and definition of the ADHD diagnosis and its subtypes or presentations (according
      to Diagnostic and Statistical Manual (DSM) IV and DSM 5), ADHD symptom severity and global
      functional impairment (by the investigator-rated ADHD Rating Scale-IV (ADHD-RS-IV) and
      Clinical Global Impression Scale-Severity and Improvement; CGI-S and CGI-I), comorbidities
      (by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinical
      interview), intellectual ability (by the WISC test), and general level of functioning (by the
      Vineland interview). Subjects previously assessed and diagnosed will be re-assessed at the
      screening visit to ascertain a current evaluation and definition of these parameters.

      At baseline, a Qb-test and an assessment of symptom severity and global functional impairment
      will be made by the investigator-rated ADHD-RS-IV and CGI-S, everyday functioning by
      parent-rated WIFRS, and quality of life by parent-rated CHIP-CE. An adverse events report
      will be collected by interview with open-ended questions. Assignment to treatment will be
      individualized according to clinical picture and patient preference.

      At subsequent visits (1, 2, 3, 6, 12, 18 and 24 months) the following assessments will be
      performed: Investigator-rated ADHD-RS-IV, CGI-S, Clinical Global Impression-Improvement
      (CGI-I) scales for symptom severity, global functional impairment and improvement. Adverse
      event report. Compliance assessment through pill count. Assessment of comorbidity status
      according to DSM-IV and DSM 5 checklist/interview.

      A Qb-test will be performed at the 1 and 12 month visits. Everyday functioning and quality of
      life will be assessed by parent-rated WIFRS and CHIP-CE scales at the 12 and 24 month visits.

      Duration of study treatment per subject is 24 months. Medication dosage is 1-3 doses daily as
      needed to optimize symptom control. Medications (methylphenidate, amphetamine, atomoxetine)
      will be provided by the pharmacy according to routines in standard clinical treatment.

      For cluster analysis of Qb-test results, retrospective data from at least 50 patients
      previously diagnosed at our clinic will be added to the data from the subjects participating
      in the prospective study, to increase sample size to ascertain sufficient power for subgroup
      (cluster) analysis.

      Safety evaluations Adverse event (AE) reports will be collected at all visits through
      open-ended questions. Vital signs (height, weight, blood pressure, pulse) will be assessed at
      all visits. AE severity should be graded: Mild, Moderate or Severe, and all AEs must be
      followed until an outcome is known, ensuring the subject's safety. All AEs will be recorded
      in the subject's medical records and in the Clinical Report Form (CRF), and also reported to
      the Medical Products Agency according to local regulations.

      Study population Approximately 100 subjects from our centre will be enrolled in the
      prospective study.

      Retrospective data for the cluster analysis will be collected from at least 50 patients
      previously diagnosed at our centre.
    

Intervention name(s): ADHD medications
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment