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

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • clonidine
• Active Comparator: 2
  • methylphenidate
• Active Comparator: 3
  • methylphenidate and clonidine
• Placebo Comparator: 4

Primary Measures

• change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
  • Time Frame: at 16 weeks
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 6 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Overall Clinical Trial Officials and Contacts

Floyd Randy Sallee, MD/PhD Principal Investigator University of Cincinnati  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414921

Study ID Number: R01NS39087_kiddie-CAT

ClinicalTrials.gov Identifier: NCT00414921

Health Authority: United States: Federal Government