- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00540826
Treatment Compliance in Children and Adolescents on ADHD Medication (COMPLY)
August 26, 2009 updated by: Eli Lilly and Company
Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice
The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting.
Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument.
A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
518
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bad Homburg, Germany, D-61350
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting.
Participating physicians may be office or hospital based psychiatrists and pediatricians throughout Germany.
Description
Inclusion Criteria:
- 6-17 years old
- diagnosis of ADHD according to ICD-10 or DSM-IV criteria
- new initiation onto an approved medication to treat ADHD
Exclusion Criteria:
- no specific exclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
A: ADHD-patients receiving non-stimulants (e.g.
atomoxetine)
|
in-label use
Other Names:
|
B
B: ADHD-patients receiving stimulants
|
in-label use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
October 5, 2007
First Submitted That Met QC Criteria
October 5, 2007
First Posted (Estimate)
October 8, 2007
Study Record Updates
Last Update Posted (Estimate)
August 27, 2009
Last Update Submitted That Met QC Criteria
August 26, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12067
- B4Z-SB-B012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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