- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414921
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) (kiddie-CAT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14618
- University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C
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Ohio
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Cincinnati, Ohio, United States, 45267-0559
- University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 4
|
inactive substance
|
Active Comparator: 1
clonidine
|
Clonidine is FDA-approved for the treatment of hypertension in adults
|
Active Comparator: 2
methylphenidate
|
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
Other Names:
|
Active Comparator: 3
methylphenidate and clonidine
|
Clonidine is FDA-approved for the treatment of hypertension in adults
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Time Frame: at 16 weeks
|
at 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: at 16 weeks
|
at 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Floyd Randy Sallee, MD/PhD, University of Cincinnati
- Principal Investigator: Oscar Bukstein, MD, Western Psychiatric Institute and Clinic
- Principal Investigator: Donna Palumbo, PhD, University of Rochester
- Principal Investigator: William Pelham, PhD, SUNY Buffalo
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympatholytics
- Methylphenidate
- Clonidine
Other Study ID Numbers
- R01NS39087_kiddie-CAT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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