We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540826
First Posted: October 8, 2007
Last Update Posted: August 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00540826     History of Changes
Other Study ID Numbers: 12067
B4Z-SB-B012
First Submitted: October 5, 2007
First Posted: October 8, 2007
Last Update Posted: August 27, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs