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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Janssen-Ortho LLC
Purdue
Shire
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00307268
First received: March 23, 2006
Last updated: January 21, 2013
Last verified: January 2013

March 23, 2006
January 21, 2013
March 2008
January 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00307268 on ClinicalTrials.gov Archive Site
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Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adolescents With ADHD: An Observational, Long-Term Follow-up Study of Routine Clinical Care

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment.

Attention-Deficit/Hyperactivity Disorder (ADHD)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
December 2012
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Meet DSM-IV criteria for ADHD

Exclusion Criteria:

None

Both
6 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00307268
H05-70361
No
University of British Columbia
University of British Columbia
  • Eli Lilly and Company
  • Janssen-Ortho LLC
  • Purdue
  • Shire
Principal Investigator: Margaret Weiss, MD, PhD The University of British Columbia
University of British Columbia
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP