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Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder

NCT00429273 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2021-07-30

Study results available
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Summary

This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

Guanfacine

Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures

DRUG

Methylphenidate (MPH)

Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.

Sponsors & Collaborators

Principal Investigators

  • James T. McCracken, MD · University of California, Los Angeles

  • James J. McGough, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00429273 on ClinicalTrials.gov