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Sponsors and Collaborators: |
University of British Columbia Janssen-Ortho Inc., Canada |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00323700 |
To determine if there is a clinically and statistically significant difference between OROS-MPH and IR MPH in ADHA and ODD symptoms by the parent completed SNAP-IV. It is hypothesized that OROS-MPH is superior in improving symptom outcomes overall, remission rate, functional improvement, quality of life and persistence with medication over time.
Condition |
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Attention-Deficit/Hyperactivity Disorder (ADHD) |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | A Naturalistic Prospective Study of Treatment Effectiveness for ADHD |
Estimated Enrollment: | 200 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
This one-year prospective observational study is designed to evaluate and compare outcomes effectiveness between OROS-MPH and IR MPH in ADHA and ODD symptoms at the ADHD Clinic of the British Columbia Children's and Women's Health Centre. A practical clinical trial is valuable because it has the potential to provide us the information which represents the actual outcomes in real settings.
The primary objective of this study is to analyze the treatment outcomes of ADHD patients under conditions of routine clinical practice. Patients will, therefore, be treated according to the current practice of each participating physician, with the exception of several additional rating scales which are SNAP-IV, Strengths and Difficulties Questionnaire, WEISS Functional Impairment Rating Scale (WFIRS)-Parent, Child Health and Illness Profile (CHIP), EQ-5D, Parent/Caregiver Questionnaire, ADHD Side Effect Checklist, Adolescent Diversion Questionnaire, Adaptive Behavior Assessment System-Second Edition (ABAS-2) and Clinic Global Impressions. Patients will be assessed at baseline and 12 months regardless of whether the original treatment is continued. If a patient terminates the study early, all assessments that are normally collected at the end of the study will be collected at the time of termination. Only patients with pre and post data will be included in the analysis.
Results of this study are expected to make breakthrough on the treatment of ADHD in practice; and, particularly, information which come out from this study is not currently available from other researches.
Ages Eligible for Study: | 16 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Children between ages of 6-18; one-year prospective observational study designed to evaluate and compare outcomes effectiveness between OROS-MPH and IR MPH in ADHA and ODD symptoms at the ADHD Clinic of the British Columbia Children's and Women's Health Centre.
Inclusion Criteria:
Exclusion Criteria:
Contact: Lian Chiu | 875-2000 ext 6553 | lchiu@cw.bc.ca |
Canada, British Columbia | |
Children's and Women's Health Center of BC | |
Vancouver, British Columbia, Canada |
Principal Investigator: | Margaret Weiss, MD | The University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Margaret Weiss ) |
Study ID Numbers: | C05-0448 |
Study First Received: | May 8, 2006 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00323700 |
Health Authority: | Canada: Health Canada |
ADHD Effectiveness ODD |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Pathologic Processes Disease Nervous System Diseases |