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.

Condition	Treatment or Intervention	Phase
Attention Deficit Disorder with Hyperactivity	Drug: clonidine  Drug: methylphenidate	Phase III

Further Study Details: 

Expected Total Enrollment:  140

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.

Ages Eligible for Study:  7 Years   -   12 Years,  Genders Eligible for Study:  Both

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.

New York
      University of Rochester, Department of Neurology, Rochester,  New York,  14642,  United States
      SUNY Buffalo, Center For Children & Families, Buffalo,  New York,  14214,  United States
Ohio
      Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States
Pennsylvania
      Western Psychiatric Institute and Clinic, Pittsburgh,  Pennsylvania,  United States

Study chairs or principal investigators

Floyd R. Sallee, M.D., Ph.D.,  Principal Investigator,  Children's Hospital Medical Center   

Study ID Numbers:  R01NS39087
Record last reviewed:  October 2004
Last Updated:  October 14, 2004
Record first received:  March 4, 2002
ClinicalTrials.gov Identifier:  NCT00031395
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08