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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Enrollment: 10
Study Start Date: March 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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

No publications provided

ClinicalTrials.gov Identifier: NCT00257725     History of Changes
Other Study ID Numbers: 4939
Study First Received: November 21, 2005
Last Updated: February 4, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014