CONCERTA Lab School Study
Completed · Phase 4 · Has a placebo group
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
Key facts
- Study ID
- NCT00799487
- Run by
- Ortho-McNeil Janssen Scientific Affairs, LLC
- People needed
- 89
- Starts
- 2009-01-02
- Expected to finish
- 2009-06-26
- Last updated by the study team
- 2020-03-12
Who can join
Age: 9 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ADHD diagnosis of all subtypes (except Not Otherwise Specified)
- Patients with total or subscale Attention Deficit Hyperactivity Disorder Rating Scale (ADHD RS-IV) scores > =90th percentile relative to the general population of children by age and gender
- Patients currently receiving ADHD medication must be inadequately managed on their current stimulant dose and meet this criteria at the screening visit
- Ability to read and understand English
- Ability to attend school regularly
You may not qualify if…
- Estimated Full Scale IQ score of 80 or below, Severe Learning Disability
- History of or current, primary diagnosis of: severe anxiety disorder, conduct disorder, psychotic disorders, Pervasive Developmental Disorder, Eating Disorder, Obsessive-Compulsive Disorder, Sleep Disorder, Major Depressive Disorder, Bipolar Disorder, Substance Use Disorder, Chronic Tic Disorder, personal or family history of Tourette's Syndrome
- Weight < 3rd percentile for age
- History of hospitalization for treatment of a mood, anxiety, or psychotic disorder
- History of failed response to methylphenidate
Where it is running
- Study site — Little Rock, Arkansas, United States
- Study site — Las Vegas, Nevada, United States
- Study site — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.