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Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

NCT00414921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-05-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of two medications--clonidine and methylphenidate--alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

clonidine

Clonidine is FDA-approved for the treatment of hypertension in adults

DRUG

methylphenidate

Methylphenidate is known to safely and effectively treat many ADHD symptoms.

OTHER

placebo

inactive substance

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Floyd Randy Sallee, MD/PhD · University of Cincinnati

  • Oscar Bukstein, MD · Western Psychiatric Institute and Clinic

  • Donna Palumbo, PhD · University of Rochester

  • William Pelham, PhD · SUNY Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-09-30
Completion
2007-06-30

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 NCT00414921 on ClinicalTrials.gov