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

University of Cincinnati

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: clonidine; Drug: methylphenidate; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00414921

R01NS39087_kiddie-CAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

clonidine

Treatment:

Drug: clonidine

2

Active Comparator group

Description:

methylphenidate

Treatment:

Drug: methylphenidate

3

Active Comparator group

Description:

methylphenidate and clonidine

Treatment:

Drug: clonidine

Drug: methylphenidate

4

Placebo Comparator group

Treatment:

Other: placebo