Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Study Overview
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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.

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.

Official Title
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Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: clonidine
* Drug: methylphenidate
* Other: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | at 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clonidine, Attention deficit hyperactivity disorder, ADHD, methylphenidate, MPH