Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: clonidine (Drug); methylphenidate (Drug); placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)

Official(s) and/or principal investigator(s):
Floyd Randy Sallee, MD/PhD, Principal Investigator, Affiliation: University of Cincinnati
Oscar Bukstein, MD, Principal Investigator, Affiliation: Western Psychiatric Institute and Clinic
Donna Palumbo, PhD, Principal Investigator, Affiliation: University of Rochester
William Pelham, PhD, Principal Investigator, Affiliation: SUNY Buffalo

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.

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

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

Primary outcome: change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)

Secondary outcome: 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.

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.

Minimum age: 4 Years. Maximum age: 6 Years. Gender(s): Both.

Criteria:

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

University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C, Rochester, New York 14618, United States

University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559, Cincinnati, Ohio 45267-0559, United States

Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street, Pittsburgh, Pennsylvania 15213, United States

Starting date: September 2003
Ending date: June 2007
Last updated: December 6, 2007