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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
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00307268     History of Changes
Other Study ID Numbers: H05-70361
Study First Received: March 23, 2006
Last Updated: January 21, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
ADHD Effectiveness

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014