- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031395
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
May 20, 2009 updated by: University of Cincinnati
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Buffalo, New York, United States, 14214
- SUNY Buffalo, Center For Children & Families
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Rochester, New York, United States, 14642
- University of Rochester, Department of Neurology
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Ohio
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Cincinnati, Ohio, United States, 45229
- Children's Hospital Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States
- Western Psychiatric Institute and Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Active Comparator: 2
|
MPH is FDA-approved for the treatment of ADHD symptoms in children.
Other Names:
|
Active Comparator: 1
|
Clonidine is FDA-approved for the treatment of hypertension in adults.
|
Placebo Comparator: 4
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an inactive substance
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Active Comparator: 3
|
Clonidine is FDA-approved for the treatment of hypertension in adults.
MPH is FDA-approved for the treatment of ADHD symptoms in children.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy outcome was 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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Floyd R. Sallee, M.D., Ph.D., Children's Hospital & Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
March 4, 2002
First Submitted That Met QC Criteria
March 4, 2002
First Posted (Estimate)
March 5, 2002
Study Record Updates
Last Update Posted (Estimate)
May 21, 2009
Last Update Submitted That Met QC Criteria
May 20, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- 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
- R01NS039087 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Attention Deficit Disorder With Hyperactivity
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