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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00414921 |
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.
Condition | Intervention | Phase |
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Attention Deficit Hyperactivity Disorder |
Drug: clonidine Drug: methylphenidate Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Preschool Supplement to Clonidine in ADHD (Kiddie-CAT) |
Enrollment: | 30 |
Study Start Date: | September 2003 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
clonidine
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Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults
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2: Active Comparator
methylphenidate
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Drug: methylphenidate
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
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3: Active Comparator
methylphenidate and clonidine
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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.
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4: Placebo Comparator |
Other: placebo
inactive substance
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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.
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C | |
Rochester, New York, United States, 14618 | |
United States, Ohio | |
University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559 | |
Cincinnati, Ohio, United States, 45267-0559 | |
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street | |
Pittsburgh, Pennsylvania, United States, 15213 |
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 |
Responsible Party: | University of Cincinnati School of Medicine ( Floyd R. Sallee, M.D., Ph.D., Professor ) |
Study ID Numbers: | R01NS39087_kiddie-CAT |
Study First Received: | December 21, 2006 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00414921 |
Health Authority: | United States: Federal Government; United States: University of Cincinnati IRB |
Attention deficit hyperactivity disorder ADHD clonidine methylphenidate MPH |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Clonidine Mental Disorders Diagnosed in Childhood |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Sympatholytics Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Central Nervous System Stimulants Cardiovascular Agents |
Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Therapeutic Uses Dopamine Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents |