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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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| 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 |
|---|---|
| 1: Active Comparator |
Drug: clonidine
Clonidine is FDA-approved for the treatment of hypertension in adults.
|
| 2: Active Comparator |
Drug: methylphenidate
MPH is FDA-approved for the treatment of ADHD symptoms in children.
|
| 3: Active Comparator |
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.
|
| 4: Placebo Comparator |
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 | |
| University of Rochester, Department of Neurology | |
| Rochester, New York, United States, 14642 | |
| SUNY Buffalo, Center For Children & Families | |
| Buffalo, New York, United States, 14214 | |
| 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: | University of Cincinnati School of Medicine ( Floyd R. Sallee, M.D., Ph.D., Professor ) |
| Study ID Numbers: | R01NS39087 |
| Study First Received: | March 4, 2002 |
| Last Updated: | May 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00031395 History of Changes |
| Health Authority: | United States: Federal Government; United States: University of Cincinnati IRB |
|
Attention Deficit Hyperactivity Disorder ADHD clonidine methylphenidate MPH |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Methylphenidate Adrenergic Agonists Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Sensory System Agents Therapeutic Uses Mental Disorders Diagnosed in Childhood |
Hyperkinesis Analgesics Sympatholytics Disease Adrenergic alpha-Agonists Clonidine Nervous System Diseases Attention Deficit and Disruptive Behavior Disorders Central Nervous System Stimulants Cardiovascular Agents Antihypertensive Agents Dyskinesias Pharmacologic Actions Autonomic Agents Neurologic Manifestations |