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Methylphenidate Study in Young Children With Developmental Disorders

NCT00517504 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-07-04

No results posted yet for this study

Summary

The purpose of this study is to determine if methylphenidate (a common brand name is Ritalin), a medicine used for treating older children with Attention Deficit and Hyperactivity Disorder (ADHD), is also safe and helpful for problems related to symptoms of ADHD in young children with Developmental Disorders (DD)

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate

* 1-week single blind placebo lead-in phase. * step-wise single blind titration of MPH at 1.25 mg bid for the first week, 2.5 mg bid for the second week , 5 mg bid for the third week, 7.5 mg bid for the fourth week and 10 mg bid for the 5th week. Dose increased if room for improvement in child's symptoms and no clinically important side effects. Dose not increased if no room for improvement in child's symptoms or if clinically important side effects. After single blind titration, child enters a 4-week double-blind randomized crossover study with placebo and child's best dose that produced maximal effect with minimal side effects, with each child serving as his/her own control.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Arizona

    lead OTHER

Principal Investigators

  • Jaswinder K Ghuman, M.D. · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
36 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2008-03-31

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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 NCT00517504 on ClinicalTrials.gov