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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307268
First Posted: March 27, 2006
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eli Lilly and Company
Janssen-Ortho LLC
Purdue
Shire
Information provided by (Responsible Party):
University of British Columbia
  Purpose
To evaluate clinical effectiveness of medication treatment for ADHD. It is hypothesized that the effectiveness is lower than efficacy outcomes measured in clinical trials

Condition
Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by University of British Columbia:

Enrollment: 195
Study Start Date: March 2008
Study Completion Date: December 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children and adolescents with a diagnosis of ADHD, aged 6 to 18 inclusive (at baseline), referred to the Provincial ADHD Program for clinical assessment.
Criteria

Inclusion Criteria:

Meet DSM-IV criteria for ADHD

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307268


Locations
Canada, British Columbia
Children's and Women's Health Centre of BC
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Eli Lilly and Company
Janssen-Ortho LLC
Purdue
Shire
Investigators
Principal Investigator: Margaret Weiss, MD, PhD The University of British Columbia
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00307268     History of Changes
Other Study ID Numbers: H05-70361
First Submitted: March 23, 2006
First Posted: March 27, 2006
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by University of British Columbia:
ADHD Effectiveness

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders