A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been withdrawn prior to enrollment.
(Merged with the study NCT00307268)
Sponsor:
Collaborator:
Janssen-Ortho Inc., Canada
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00323700
First received: May 8, 2006
Last updated: April 17, 2009
Last verified: April 2009
  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)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Naturalistic Prospective Study of Treatment Effectiveness for ADHD

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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
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: NCT00323700

Sponsors and Collaborators
University of British Columbia
Janssen-Ortho Inc., Canada
Investigators
Principal Investigator: Margaret Weiss, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Margaret Weiss, University of British Columbia
ClinicalTrials.gov Identifier: NCT00323700     History of Changes
Other Study ID Numbers: C05-0448
Study First Received: May 8, 2006
Last Updated: April 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
ADHD
Effectiveness
ODD

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

ClinicalTrials.gov processed this record on October 22, 2014