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Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD
This study is currently recruiting participants.
Verified by University of British Columbia, April 2009
First Received: March 23, 2006   Last Updated: April 17, 2009   History of Changes
Sponsors and Collaborators: University of British Columbia
Eli Lilly and Company
Janssen-Ortho LLC
Purdue
Shire Pharmaceutical Development
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00307268
  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: Cohort, 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Study Completion Date: December 2009
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307268

Contacts
Contact: Lauren Giles 604-875-2000 ext 6474 lgiles@cw.bc.ca

Locations
Canada, British Columbia
Children's and Women's Health Centre of BC Recruiting
Vancouver, British Columbia, Canada
Contact: Lauren Giles     604-875-2000 ext 6464     lgiles@cw.bc.ca    
Principal Investigator: Margaret Weiss, MD, PhD            
Sponsors and Collaborators
University of British Columbia
Eli Lilly and Company
Janssen-Ortho LLC
Purdue
Shire Pharmaceutical Development
Investigators
Principal Investigator: Margaret Weiss, MD, PhD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia ( Dr. Margaret Weiss )
Study ID Numbers: C05-0361
Study First Received: March 23, 2006
Last Updated: April 17, 2009
ClinicalTrials.gov Identifier: NCT00307268     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
ADHD Effectiveness

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Neurologic Manifestations
Hyperkinesis
Dyskinesias

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

ClinicalTrials.gov processed this record on September 11, 2009