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Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children

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ClinicalTrials.gov Identifier: NCT00031395
Recruitment Status : Completed
First Posted : March 5, 2002
Last Update Posted : May 21, 2009
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Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: clonidine Drug: methylphenidate Other: placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
Study Start Date : September 1999
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) [ Time Frame: at 16 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031395

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
Sponsors and Collaborators
University of Cincinnati
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Floyd R. Sallee, M.D., Ph.D. Children's Hospital & Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: R01NS039087 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2002    Key Record Dates
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by University of Cincinnati:
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists