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Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Clinical research trials and Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children. Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children clinical trial. Participants typically obtain the most effective healthcare available for their Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children  Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
For Condition: Attention Deficit Disorder with Hyperactivity
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The purpose of this study is to evaluate the benefits and side effects of two medications used alone or in combination to treat attention deficit hyperactivity disorder (ADHD) in children.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: 7 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Children aged 7 through 12 in school. - All subjects must meet DSM IV criteria for the diagnosis of ADHD of any subtype [21]. - Each subject must also satisfy the following criteria regarding the severity of ADHD symptoms: 1. ADHD must be viewed as clinically significant and worthy of treatment by medications as judged by the parent and the site investigator. Operationally, medication treatment will be considered indicated for any subject who has ADHD symptoms that significantly interfere with academic or social functioning and that have not improved (or are not expected to improve) sufficiently with non-pharmacological interventions (e.g., modifying the classroom environment, tutoring). 2. The site investigator's rating of global functioning on the C-GAS must yield a score of 70 or below. Scores below 70 on the C-GAS are designated as indicating abnormal function [22]. The score of 70 corresponds to the anchor point description: "Some difficulty in a single area, but generally functioning pretty well." - Screen of Intelligence using the vocabulary and block design subtests of the Wechsler Intelligence Scale for Children-Third Edition indicates an estimated I.Q > 70. - Informed consent/assent signed. We will not enroll any child who does not want to participate. - The designated school for each subject agrees to participate in the study by completing all required questionnaires and following all specified procedures. - The child must be able to swallow the tablets and capsules used in this study. Exclusion Criteria: - Subjects with tic disorder of any type or tic symptoms, a primary diagnosis of major depression, pervasive developmental disorder, autism, any psychotic disorder, and mental retardation (based on current DSM criteria) will be excluded. We will not exclude subjects with obsessive-compulsive disorder, oppositional-defiant disorder or conduct disorder. - The presence of a known medical condition that would preclude the use of MPH or clonidine. - Known pregnancy. A urinary pregnancy test will be performed for all menstruating female subjects. Female subjects of child bearing potential will be advised not to become pregnant. In this circumstance, study medication will be tapered and discontinued and the subject will be terminated from the study. A urinary pregnancy test will be repeated at the end of the study. Subjects who request information regarding possible birth control mechanisms will be referred to their primary care physicians. - Known presence of impaired renal function. A routine urinalysis will be performed for each subject to exclude signs of renal failure. - Known active cardiovascular disease/anomaly, which would be a contraindication for the use of MPH or clonidine. - Subjects may not receive any other medication for the treatment of ADHD. Treatment with MPH or other stimulants must be discontinued for at least 2 weeks prior to enrollment and treatment with other medications to treat ADHD (e.g., antidepressants, clonidine) must be discontinued for at least 6 weeks prior to enrollment. - Subjects may not receive any other psychotropic medication (e.g., serotonin reuptake inhibitors), anxiolytics (e.g., clonazepam) or hypnotics. Any such medication must be discontinued at least 6 weeks prior to enrollment. - Previous use of MPH or clonidine will be permitted.
Total Enrollment: 140
Location and Contact Information:
Overall Study Official:
FloydSallee, Principal Investigator, Children's Hospital Medical Center
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
SUNY Buffalo, Center For Children & Families
Buffalo, New York, 14214
United States
University of Rochester, Department of Neurology
Rochester, New York, 14642
United States
Additional Information:
Study ID Numbers: R01NS39087;
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031395
Other Attention Deficit Disorder With Hyperactivity Studies:
1. Genetic Analysis of Attention Deficit Hyperactivity Disorder (ADHD)
2. Study of Attention Deficit/Hyperactivity Disorder Using Transcranial Magnetic Stimulation
3. Preventing Behavior Problems in Children with ADHD
4. Brain Imaging in Children With AD/HD
5. Treatment of Attention Deficit Hyperactivity Disorder in Preschool-Age Children (PATS)
Related Studies:
Other Attention Deficit Disorder with Hyperactivity Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
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