Clinical trial NCT00414921: Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Official title: Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention deficit hyperactivity disorder
ADHD
clonidine
methylphenidate
MPH
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-12-22
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
timeFrame: at 16 weeks
Secondary outcomes:
measure: 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.
timeFrame: at 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559
state: Ohio
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street
state: Pennsylvania
Study officials:
affiliation: University of Cincinnati
name: Floyd Randy Sallee, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Psychiatric Institute and Clinic
name: Oscar Bukstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Donna Palumbo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Buffalo
name: William Pelham, PhD
role: PRINCIPAL_INVESTIGATOR
References: