Long Duration Stimulant Treatment Study of Preschoolers With ADHD-Feasibility Study

This study has been completed.
Sponsor:
Information provided by:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00257725
First received: November 21, 2005
Last updated: February 4, 2009
Last verified: February 2009

November 21, 2005
February 4, 2009
March 2005
March 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00257725 on ClinicalTrials.gov Archive Site
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Long Duration Stimulant Treatment Study of Preschoolers With ADHD-Feasibility Study
Not Provided

This study will evaluate if Ritalin LA™ is safe and effective for ADHD treatment in 4-to-5-year olds.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Drug: Ritalin LA™
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Parent/legal guardian provided informed consent; child provided verbal assent
  2. Parent and child must be English-speaking
  3. Child must be in good physical health
  4. Child must be stimulant-naïve, OR not on ADHD medication, OR taking ADHD medication but not finding it helpful
  5. Child must have an IQ of at least 70
  6. Child must be in an educational setting (e.g., pre-school, kindergarten, elementary school program) at least two half days weekly

Exclusion Criteria:

  1. Child with adjustment disorder, autism, psychosis, bipolar disorder, significant suicidality, or any other psychiatric disorder
  2. Child with current or history of physical, sexual, or emotional abuse
  3. Child with history of intolerance to stimulant medications
  4. Child who did not respond to adequate stimulant medication trials
  5. Child taking medications that are excluded in the study
  6. Child and parent refusing to comply with study procedures
Both
4 Years to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00257725
4939
No
Not Provided
New York State Psychiatric Institute
Not Provided
Principal Investigator: Laurence L Greenhill, MD New York State Psychiatric Insitute
New York State Psychiatric Institute
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP