Treatment Compliance in Children and Adolescents on ADHD Medication

NCT ID: NCT00540826

Last Updated: 2009-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

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

Atomoxetine

Intervention Type DRUG

in-label use

B

B: ADHD-patients receiving stimulants

stimulants (any approved ADHD medication)

Intervention Type DRUG

in-label use

Interventions

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Atomoxetine

in-label use

Intervention Type DRUG

stimulants (any approved ADHD medication)

in-label use

Intervention Type DRUG

Other Intervention Names

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Strattera

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24705867 (View on PubMed)

Other Identifiers

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B4Z-SB-B012

Identifier Type: -

Identifier Source: secondary_id

12067

Identifier Type: -

Identifier Source: org_study_id

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