NCT00866996

Brief Summary

The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evaluated by physicians and parents in a community setting.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,323

participants targeted

Target at P75+ for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
Last Updated

May 24, 2011

Status Verified

March 1, 2010

First QC Date

March 19, 2009

Last Update Submit

May 20, 2011

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention deficit hyperactivity disorderMethylphenidateAtomoxetineConcerta

Outcome Measures

Primary Outcomes (1)

  • Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.

Secondary Outcomes (1)

  • CGI-I and each PSQ item separately were summarized by descriptive statistics and frequency distributions. Treatment effects were tested by chi-square statistics. Onset of effect was assessed by PSQ on Days 2 to 13.

Interventions

Methylphenidate extended-release; AtomoxetineDRUG

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients who met the DSM-IV criteria for a primary diagnosis of ADHD of any subtype (may have been newly diagnosed with ADHD and not on treatment)
  • score of 24 or higher on the ADHD Rating Scale (ADHD-RS) at screening
  • physician must have rated the patient as "Moderately ill" or worse on the CGI-S at screening
  • children may have been enrolled who were not receiving adequate treatment for ADHD (based on clinical judgment in consultation with the parent)
  • children must have been washed-out of their current treatment a minimum of 3 days or 5 half lives of the medication whichever was longer
  • and the child and parent must have given written informed consent, and assent, where applicable.

You may not qualify if:

  • Female child who had experienced menarche
  • presence of eating or substance disorder or co-morbid psychiatric condition other than oppositional defiant disorder
  • history of seizure, tic disorder, mental retardation, severe developmental disorder (i.e. severe cerebral palsy, autism) or family history of Tourette's Disorder
  • required medications as excluded by the package inserts for Concerta or Strattera
  • diagnosed with hyperthyroidism or glaucoma
  • and known non-responders to treatments indicated for ADHD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kemner JE, Starr HL, Ciccone PE, Hooper-Wood CG, Crockett RS. Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study. Adv Ther. 2005 Sep-Oct;22(5):498-512. doi: 10.1007/BF02849870.

    PMID: 16418159RESULT

  • Starr HL, Kemner J. Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD. J Natl Med Assoc. 2005 Oct;97(10 Suppl):11S-16S.

    PMID: 16350601RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2009

First Posted

March 23, 2009

Study Completion

December 1, 2003

Last Updated

May 24, 2011

Record last verified: 2010-03