|
|
|
|
|
Sponsored by: |
New York State Psychiatric Institute |
Information provided by: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00257725 |
This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.
Condition | Intervention | Phase |
Attention Deficit Disorder With Hyperactivity |
Drug: Ritalin LA™ |
Phase IV |
MedlinePlus related topics: | Attention Deficit Hyperactivity Disorder |
ChemIDplus related topics: | Methylphenidate hydrochloride Methylphenidate |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Estimated Enrollment: | 10 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2008 |
This is a single site, open-label, four-week feasibility study of long-duration beaded methylphenidate (B-MPH), also known as Ritalin LA™. B-MPH is a FDA-approved medication for children 6 years and older with attention-deficit/hyperactivity disorder (ADHD), but there are no studies of its use in preschoolers. This study will evaluate the safety and effectiveness of B-MPH for ADHD treatment in 4-to-5-year old children.
Total study duration is approximately 5 weeks. It includes a screening evaluation and 4 weeks of B-MPH treatment with doses ranging from 10 to 30 mg (based on the individual tolerability and efficacy). The study doctor will conduct parent-training sessions during the treatment visits.
Ages Eligible for Study: | 4 Years to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |||||
New York State Psychiatric Insitute | |||||
New York, New York, United States, 10032 |
New York State Psychiatric Institute |
Principal Investigator: | Laurence L Greenhill, MD | New York State Psychiatric Insitute |
Study ID Numbers: | 4939 |
First Received: | November 21, 2005 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00257725 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|