Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

clonidine

Group Type ACTIVE_COMPARATOR

clonidine

Intervention Type DRUG

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

2

methylphenidate

Group Type ACTIVE_COMPARATOR

methylphenidate

Intervention Type DRUG

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

3

methylphenidate and clonidine

Group Type ACTIVE_COMPARATOR

clonidine

Intervention Type DRUG

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

methylphenidate

Intervention Type DRUG

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

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

inactive substance

Interventions

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clonidine

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

Intervention Type DRUG

methylphenidate

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

Intervention Type DRUG

placebo

inactive substance

Intervention Type OTHER

Other Intervention Names

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MPH

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No