Treatment Compliance in Children and Adolescents on ADHD Medication (COMPLY)

Lilly

Status: Completed

Conditions: ADHD

Treatments: Drug: stimulants (any approved ADHD medication); Drug: Atomoxetine

Study type: Observational

Funder types: Industry

Identifiers

NCT00540826

12067

B4Z-SB-B012

Details and patient eligibility

About

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.

Enrollment: 518 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

518 participants in 2 patient groups

A

Description:

A: ADHD-patients receiving non-stimulants (e.g. atomoxetine)

Treatment:

Drug: Atomoxetine

B

Description:

B: ADHD-patients receiving stimulants

Treatment:

Drug: stimulants (any approved ADHD medication)