Treatment Compliance in Children and Adolescents on ADHD Medication

NCT00540826 | Completed

• 2 other identifiers: 12067B4Z-SB-B012
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Study Arms (2)

A

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

Drug: Atomoxetine

B

B: ADHD-patients receiving stimulants

Drug: stimulants (any approved ADHD medication)

Interventions

Atomoxetine DRUG

in-label use

Also known as: Strattera

A

stimulants (any approved ADHD medication) DRUG

in-label use

B

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• years old
• diagnosis of ADHD according to ICD-10 or DSM-IV criteria
• new initiation onto an approved medication to treat ADHD

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, D-61350, Germany

Location

Related Publications (1)

• 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 DERIVED

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride; Central Nervous System Stimulants

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: November 1, 2007
• Study Completion: June 1, 2009
• Last Updated: August 27, 2009

Record last verified: 2009-08

Locations

DE (1)