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Sponsors and Collaborators: |
University of British Columbia Eli Lilly and Company Janssen-Ortho LLC Purdue Shire Pharmaceutical Development |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00307268 |
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 |
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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 |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2009 |
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.
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | 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.
Inclusion Criteria:
Meet DSM-IV criteria for ADHD
Exclusion Criteria:
None
Contact: Lauren Giles | 604-875-2000 ext 6474 | lgiles@cw.bc.ca |
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 |
Principal Investigator: | Margaret Weiss, MD, PhD | The University of British Columbia |
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 |
ADHD Effectiveness |
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 |
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 |