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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00307268
Other study ID # H05-70361
Secondary ID
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, 

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