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Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children

NCT00754208 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-10-05

Study results available
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Summary

This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children.

Hypotheses

1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children.
2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

methylphenidate

Starting dose: methylphenidate (immediate-release pill) or Methylin (immediate-release chewable tablet for those unable to swallow pills) 2.5mg Q AM and Q noon. Target dose of 1mg/kg/day. Titration will occur as follows: 5mg Q AM and Q noon, then 7.5mg Q AM and Q noon, then 10mg Q AM and Q noon, as tolerated, not to exceed 30mg per day. Once each child arrives at a stable dose with a good response and good tolerability, they will be converted to the closest Ritalin LA dose, with a target dose of 1mg/kg/day.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Joan Daughton, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-18
Primary Completion
2010-01-01
Completion
2010-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00754208 on ClinicalTrials.gov