Clinical Trial: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
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.
Detailed Summary: 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.
Sponsor: University of Cincinnati
Current Primary Outcome: Efficacy outcome was change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) [ Time Frame: at 16 weeks ]
Original Primary Outcome:
Current Secondary Outcome: 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 ]
Original Secondary Outcome:
Information By: University of Cincinnati
Dates:
Date Received: March 4, 2002
Date Started: September 1999
Date Completion:
Last Updated: May 20, 2009
Last Verified: May 2009
