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Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil

NCT01228604 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-07-21

No results posted yet for this study

Summary

This study is an open-label, 6 month trial, of immediate release methylphenidate (MPH-IR) for children with ADHD aimed at assessing whether the observable behavioral changes seen during treatment are associated with potentially more stable underlying modifications in brain functioning (resting-state functional connectivity). Additionally, we will also be looking at treatment effects on neuropsychological processes and reading skills. This information will contribute to the first Brazilian study assessing the cost-effectiveness of the treatment of ADHD. Children with ADHD will be compared to a sample of sex and age-matched sample of typically developing children.

Conditions

  • Attention-deficit/Hyperactivity Disorder

Interventions

DRUG

methylphenidate (Ritalin®)

The scheme provides for initial dose of 0.3 mg / kg / day, with an average dose of 1mg/kg/day. The increases will be made considering the presentation of the drug (10mg), which allows increments of 5mg or 10mg, which will be made in clinical review, as the clinical symptoms, including increasing the dose until there is more room for improvement or there is presence of significant adverse effects, all the patients with indication of treatment will be assessed before the use of medication, 15 days, 30 days, 3 and 6 months after the start,

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Brazil

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 NCT01228604 on ClinicalTrials.gov