Treatment Compliance in Children and Adolescents on ADHD Medication

NCT00540826 — Completed, 518 participants, Eli Lilly and Company

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice

RegistryNCT00540826, acronym COMPLY
StatusCompleted
Study typeObservational
Enrollment518 (Actual)
SponsorEli Lilly and Company (Industry)
ConditionsADHD
InterventionsAtomoxetine, stimulants (any approved ADHD medication) (Drug)
Datesstart 2007-11-01, completion 2009-06-01, first posted 2007-10-08, last updated 2009-08-27
Locations1 site in Germany

Related Papers Related Patents Related Grants Related Experts
All trials for ADHD All trials of Atomoxetine All trials of stimulants (any approved ADHD medication)

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
ADrug: AtomoxetineA: ADHD-patients receiving non-stimulants (e.g. atomoxetine)
BDrug: stimulants (any approved ADHD medication)B: ADHD-patients receiving stimulants
  • Atomoxetine (Drug), also known as Strattera: in-label use
  • stimulants (any approved ADHD medication) (Drug): in-label use

+Eligibility

Sex: All, ages: 6 Years to 17 Years

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

+Locations (1)

FacilityCityCountryStatus
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 HomburgGermany

+Publications

  • Results publication: Dittmann RW, Banaschewski T, Schacht A, Wehmeier PM. Findings from the observational COMPLY study in children and adolescents with ADHD: core symptoms, ADHD-related difficulties, and patients' emotional expression during psychostimulant or nonstimulant ADHD treatment. Atten Defic Hyperact Disord. 2014 Dec;6(4):291-302. doi: 10.1007/s12402-014-0136-z. Epub 2014 Apr 6. PMID 24705867

+Investigators

  • Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company