Clinical trial NCT00323700: A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: A Naturalistic Prospective Study of Treatment Effectiveness for ADHD
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: ADHD
Effectiveness
ODD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Janssen-Ortho Inc., Canada
First posted: 2006-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of British Columbia
name: Margaret Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: