Long-term Effects of Medication for ADHD

NCT03250013 | Completed Phase 4

• 1 other identifier: LMA trial Goteborg
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

• Change in CGI - (S and I)

  Investigator-rated clinical global impression scale - severity and improvement

  0, 1, 2, 3, 6, 12, 18 and 24 months

Secondary Outcomes (6)

• ADHD Rating Scale

  0, 1, 2, 3, 6, 12, 18 and 24 months

• Qb-test

  0, 1 and 12 months

• WISC-IV

  0 and 12 months

• Vineland scale

  0 and 12 months

• Weiss Functional Impairment Scale (WFIRS)

  0, 12 and 24 months

Study Arms (1)

Children and adolescents with ADHD

EXPERIMENTAL

Children and adolescents medicating for ADHD of any subtype (presentation) with comorbidities

Drug: ADHD medications

Interventions

ADHD medications DRUG

Children and adolescents with ADHD

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Child Neuropsychiatry Unit, Sahlgrenska University Hospital

Gothenburg, 41118, Sweden

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mats Johnson, MD, PhD

  Child Neuropsychiatry Unit, Sahlgrenska University Hospital, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 15, 2017
• Study Start: April 1, 2014
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)