A Phase 2 interventional study of clonidine and methylphenidate in Attention Deficit Hyperactivity Disorder, sponsored by University of Cincinnati. Completed at 3 sites in United States. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2009-05-21.
Sponsored by University of Cincinnati · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of two medications--clonidine and methylphenidate--alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6.
Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home, work, or social settings. ADHD does not have clear physical signs that can be seen in an x-ray or a lab test. The disorder only can be identified by looking for certain behaviors, which vary from person to person.
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 approved by the Food and Drug Administration (FDA) 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 safely and effectively treat many ADHD symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms, and the long-term effectiveness of these medications is not well-known.
In this study, participants will be randomly selected to receive one of four treatments: 1) clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance). Participation in the study is about 16 weeks, and includes a baseline screening and 5 evaluation visits to assess attention, hyperactivity, overall improvement and general functioning, medication side effects, blood pressure, pulse, and weight.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
clonidine
Drug: clonidine
methylphenidate
Drug: methylphenidate
methylphenidate and clonidine
Drug: clonidine · Drug: methylphenidate
Other: placebo
Clonidine is FDA-approved for the treatment of hypertension in adults
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
Also known as: MPH
inactive substance
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Time frame: at 16 weeks
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
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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University of Cincinnati