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

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307268
• Other study ID #: H05-70361
• Status: Completed
• Phase: N/A
• First received: March 23, 2006
• Last updated: January 21, 2013
• Start date: March 2008
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

Meet DSM-IV criteria for ADHD

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder (ADHD)

Locations

Country	Name	City	State
Canada	Children's and Women's Health Centre of BC	Vancouver	British Columbia

Sponsors (5)

Lead Sponsor	Collaborator
University of British Columbia	Eli Lilly and Company, Janssen-Ortho LLC, Purdue, Shire

Country where clinical trial is conducted

Canada,