Treatment Compliance in Children and Adolescents on ADHD Medication

Completed

• Conditions: ADHD
• Interventions: Drug: stimulants (any approved ADHD medication); Drug: Atomoxetine

• Registration Number: NCT00540826
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Study Start: 2007-11
• Study Completion: 2009-06
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-26
• Last Update Posted: 2009-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 518

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	stimulants (any approved ADHD medication)	B: ADHD-patients receiving stimulants
A	Atomoxetine	A: ADHD-patients receiving non-stimulants (e.g. atomoxetine)

Trial Locations

Locations (1)

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.; 🇩🇪 Bad Homburg, Germany