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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00323700
Recruitment Status : Withdrawn (Merged with the study NCT00307268)
First Posted : May 9, 2006
Last Update Posted : April 21, 2009
Sponsor:
Collaborator:
Janssen-Ortho Inc., Canada
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date May 8, 2006
First Posted Date May 9, 2006
Last Update Posted Date April 21, 2009
Study Start Date December 2008
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)
Official Title A Naturalistic Prospective Study of Treatment Effectiveness for ADHD
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Attention-Deficit/Hyperactivity Disorder (ADHD)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Estimated Enrollment
 (submitted: May 8, 2006)
200
Original Enrollment Same as current
Estimated Study Completion Date December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT00323700
Other Study ID Numbers C05-0448
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Margaret Weiss, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Janssen-Ortho Inc., Canada
Investigators
Principal Investigator: Margaret Weiss, MD The University of British Columbia
PRS Account University of British Columbia
Verification Date April 2009