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A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)
This study is not yet open for participant recruitment.
Verified by University of British Columbia, September 2008
Sponsors and Collaborators: University of British Columbia
Janssen-Ortho Inc., Canada
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00323700
  Purpose

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
Attention-Deficit/Hyperactivity Disorder (ADHD)

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: A Naturalistic Prospective Study of Treatment Effectiveness for ADHD

Further study details as provided by University of British Columbia:

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  1. Patients between the ages of 6 and 18.
  2. Enrolled in school with at least 1 school year remaining before completion of high school.
  3. Current drug therapy with either a IR MPH or OROS MPH.

Exclusion Criteria:

  1. Parent/caregiver unable or unwilling to provide written informed consent.
  2. Child unable or unwilling to provide assent (for children aged 7 years).
  3. Parent/caregiver unable or unwilling to complete questionnaires.
  4. Child unable or unwilling to complete questionnaires ADHD is considered by the clinician to be secondary to another more serious disorder such as personality disorder, substance abuse, bipolar disorder, autism, or mental handicap.
  5. Participation in another treatment study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323700

Contacts
Contact: Lian Chiu 875-2000 ext 6553 lchiu@cw.bc.ca

Locations
Canada, British Columbia
Children's and Women's Health Center of BC
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Janssen-Ortho Inc., Canada
Investigators
Principal Investigator: Margaret Weiss, MD The University of British Columbia
  More Information

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

Keywords provided by University of British Columbia:
ADHD
Effectiveness
ODD

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009