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

This study is ongoing, but not recruiting participants.

Sponsored by: New York State Psychiatric Institute
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00257725
  Purpose

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Further study details as provided by New York State Psychiatric Institute:

Estimated Enrollment:   10
Study Start Date:   March 2005
Estimated Study Completion Date:   March 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257725

Locations
United States, New York
New York State Psychiatric Insitute    
      New York, New York, United States, 10032

Sponsors and Collaborators
New York State Psychiatric Institute

Investigators
Principal Investigator:     Laurence L Greenhill, MD     New York State Psychiatric Insitute    
  More Information


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

Keywords provided by New York State Psychiatric Institute:
ADHD  
Attention-deficit/hyperactivity disorder (ADHD)  

Study placed in the following topic categories:
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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