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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00540826
First received: October 5, 2007
Last updated: August 26, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
ADHD
 Drug: Atomoxetine
Drug: stimulants (any approved ADHD medication)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Enrollment: 518
Study Start Date: November 2007
Study Completion Date: June 2009
Groups/Cohorts Assigned Interventions
A
A: ADHD-patients receiving non-stimulants (e.g. atomoxetine)
 Drug: Atomoxetine
in-label use
Other Name: Strattera
B
B: ADHD-patients receiving stimulants
 Drug: stimulants (any approved ADHD medication)
in-label use

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540826

Locations
Germany
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, D-61350
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00540826     History of Changes
Other Study ID Numbers: 12067, B4Z-SB-B012
Study First Received: October 5, 2007
Last Updated: August 26, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Central Nervous System Stimulants
Atomoxetine
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013