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

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

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's and Women's Health Centre of BC

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meet DSM-IV criteria for ADHD

Exclusion criteria

None

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

Eli Lilly and Company
Janssen-Ortho LLC
Purdue University
Shire

Registry information

Official study title

Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2012
First posted: Mar 27, 2006
Registry last updated: Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed