NCT01228604

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

COST-EFFECTIVENESS STUDY OF THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER IN BRAZIL

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: Male
• Age: 8 Years – 10 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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,

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-10-26
• Last updated: 2014-07-21

Locations

1 site across 1 country: Brazil