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Study of Atomoxetine and OROS Methylphenidate to Treat Children and Adolescents Ages 6-17 With ADHD

NCT00585910 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2012-11-14

Study results available
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Summary

The purpose of this study is to evaluate the safety, effectiveness, and tolerability of atomoxetine and OROS methylphenidate, taken together, in the treatment of ADHD in children and adolescents ages 6-17.

Conditions

  • ADHD
  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Atomoxetine and OROS Methylphenidate

Subjects must have at least attempted to tolerate a dose of 1.2 mg/kg of atomoxetine. If tolerated, they must remain on this dose for at least two weeks. OROS methylphenidate will be target dosed and titrated to a maximum dose of 54 mg.

Sponsors & Collaborators

  • Ortho-McNeil Janssen Scientific Affairs, LLC

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Timothy Wilens, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585910 on ClinicalTrials.gov