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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257725
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : February 5, 2009
Information provided by:
New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Ritalin LA™ Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257725

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United States, New York
New York State Psychiatric Insitute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
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Principal Investigator: Laurence L Greenhill, MD New York State Psychiatric Insitute
Layout table for additonal information Identifier: NCT00257725    
Other Study ID Numbers: 4939
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009
Keywords provided by New York State Psychiatric Institute:
Attention-deficit/hyperactivity disorder (ADHD)
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents