Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00323700
Status:
WITHDRAWN
Last Update Posted:
2009-04-21
First Post:
2006-05-08
Brief Title:
A Naturalistic Prospective Study of Treatment Effectiveness for Attention-DeficitHyperactivity Disorder ADHD
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Naturalistic Prospective Study of Treatment Effectiveness for ADHD
Status:
WITHDRAWN
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Merged with the study NCT00307268
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens and Womens 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 ParentCaregiver 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
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 ParentCaregiver 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None