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| Sponsor: | University of Cincinnati |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00031395 |
Purpose
The purpose of this study is to determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: clonidine Drug: methylphenidate Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT) |
| Enrollment: | 122 |
| Study Start Date: | September 1999 |
| Study Completion Date: | June 2007 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults.
|
| Active Comparator: 2 |
Drug: methylphenidate
MPH is FDA-approved for the treatment of ADHD symptoms in children.
Other Name: MPH
|
| Active Comparator: 3 |
Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults.
Drug: methylphenidate
MPH is FDA-approved for the treatment of ADHD symptoms in children.
Other Name: MPH
|
| Placebo Comparator: 4 |
Other: placebo
an inactive substance
|
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 FDA-approved 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 be safe and effective for the treatment of many ADHD symptoms. Such medicines, however, do not cure the condition or improve all of the symptoms of ADHD, and the long-term effectiveness of these medications is not well-known. In this study the participants will be randomly selected to receive one of four treatments: 1.) clonidine; 2.) MPH; 3.) clonidine and MPH; or 4.) a placebo (which is not an active medication, but a substance that is thought to have no biological effect). The time participation in the study is 16 weeks.
Eligibility| Ages Eligible for Study: | 7 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| SUNY Buffalo, Center For Children & Families | |
| Buffalo, New York, United States, 14214 | |
| University of Rochester, Department of Neurology | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Western Psychiatric Institute and Clinic | |
| Pittsburgh, Pennsylvania, United States | |
| Principal Investigator: | Floyd R. Sallee, M.D., Ph.D. | Children's Hospital Medical Center |
More Information
| Responsible Party: | Floyd R. Sallee, M.D., Ph.D., Professor, University of Cincinnati School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00031395 History of Changes |
| Other Study ID Numbers: | R01NS39087 |
| Study First Received: | March 4, 2002 |
| Last Updated: | May 20, 2009 |
| Health Authority: | United States: Federal Government; United States: University of Cincinnati IRB |
|
Attention Deficit Hyperactivity Disorder ADHD clonidine methylphenidate MPH |
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Clonidine Methylphenidate Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Central Nervous System Agents Dopamine Uptake Inhibitors Dopamine Agents |