Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) (kiddie-CAT)

May 20, 2009 updated by: University of Cincinnati
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home, work, or social settings. ADHD does not have clear physical signs that can be seen in an x-ray or a lab test. The disorder only can be identified by looking for certain behaviors, which vary from person to person.

This trial will compare the benefits and side effects of two medications--clonidine and methylphenidate (MPH)--used alone or in combination to treat ADHD in children. MPH is approved by the Food and Drug Administration (FDA) for the treatment of ADHD symptoms in children, and clonidine is FDA-approved for the treatment of hypertension in adults. Stimulant medications such as MPH are known to safely and effectively treat many ADHD symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms, and the long-term effectiveness of these medications is not well-known.

In this study, participants will be randomly selected to receive one of four treatments: 1) clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance). Participation in the study is about 16 weeks, and includes a baseline screening and 5 evaluation visits to assess attention, hyperactivity, overall improvement and general functioning, medication side effects, blood pressure, pulse, and weight.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14618
        • University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0559
        • University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Child with ADHD
  • Child ages 4 through 6
  • Child attending a structured preschool or daycare

Exclusion Criteria:

  • Presence of a tic disorder of any kind or a known active heart disease for which it would be unsafe to use the study drugs
  • Presence of pervasive developmental disorder, autism, mental retardation, or serious psychiatric illness
  • Child not attending a structured preschool or daycare

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Other: placebo
inactive substance
Active Comparator: 1
clonidine
Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults
Active Comparator: 2
methylphenidate
Drug: methylphenidate
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
Other Names:
  • MPH
Active Comparator: 3
methylphenidate and clonidine
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 Names:
  • MPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Time Frame: at 16 weeks
at 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
the ASQ-Parent (ASQ-P) and Child Global Assessment Scales (C-GAS). Adverse events were monitored using AE logs, the Pittsburgh Side Effects Rating Scale, vital signs and electrocardiograms.
Time Frame: at 16 weeks
at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Floyd Randy Sallee, MD/PhD, University of Cincinnati
  • Principal Investigator: Oscar Bukstein, MD, Western Psychiatric Institute And Clinic
  • Principal Investigator: Donna Palumbo, PhD, University of Rochester
  • Principal Investigator: William Pelham, PhD, SUNY Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2009

Last Update Submitted That Met QC Criteria

May 20, 2009

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NS39087_kiddie-CAT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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