Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

NCT ID: NCT00307268

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-12-31

Brief Summary

To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

Detailed Description

This is a prospective, long-term, observational study of routine clinical care. The study measurements will be integrated into the clinical assessment and follow-up procedures of the outpatient services under the Provincial ADHD Program. The study is designed for systematic follow-up of children and adolescents, diagnosed with ADHD irrespective of comorbidity or whether they elect to receive medication treatment. Evaluations occur every 6 months for 24 months. The population to be examined is children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment. No studies have been conducted that have evaluated the outcome of core ADHD symptoms in a clinic setting. Metaanalysis of clinical trials of medication treatment for ADHD have suggested an effect size of approximately 0.8. Because of the heterogeneity of the clinic sample, a much lower effect size can be anticipated. Two hundred patients will be enrolled in this study with primary measure of effectiveness being change in ADHD symptoms.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Meet DSM-IV criteria for ADHD

Exclusion Criteria

None

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Janssen-Ortho LLC

INDUSTRY

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

Shire

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Weiss, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

Children's and Women's Health Centre of BC

Vancouver, British Columbia, Canada

Countries

Canada

References

Craig SG, Weiss MD, Hudec KL, Gibbins C. The Functional Impact of Sleep Disorders in Children With ADHD. J Atten Disord. 2020 Feb;24(4):499-508. doi: 10.1177/1087054716685840. Epub 2017 Jan 16.

Reference Type: DERIVED

PMID: 28093033 (View on PubMed)

Other Identifiers

H05-70361

Identifier Type: -

Identifier Source: org_study_id