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

NCT00323700 | Withdrawn

• 1 other identifier: C05-0448
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD; Effectiveness; ODD

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Parent/caregiver unable or unwilling to provide written informed consent.
• Child unable or unwilling to provide assent (for children aged 7 years).
• Parent/caregiver unable or unwilling to complete questionnaires.
• 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.
• Participation in another treatment study.

Sponsors & Collaborators

• University of British Columbia: lead
• Janssen-Ortho Inc., Canada: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Margaret Weiss, MD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2006
• First Posted: May 9, 2006
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 21, 2009

Record last verified: 2009-04