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

Phase 4

Completed

• Conditions: Attention-deficit/Hyperactivity Disorder
• Interventions: Drug: methylphenidate (Ritalin®)

• Registration Number: NCT01228604
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Study Start: 2010-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

Inclusion Criteria

The study will include 20 boys aged 8 to 10 years old, regularly enrolled in local schools and directed to the research through advertisement in the media, contact with schools or directly referred to the Attention Deficit/Hyperactivity Program (ProDAH/HCPA) by primary care services for assessment and treatment. Only children with a primary diagnosis of ADHD or with the comorbidity ADHD + reading disorder or ADHD + ODD will be included. Only drug-naïve subjects will be apt to participate in the study.

Exclusion Criteria

Children who fit into one or more of the following conditions will not be considered eligible to take part in the study: (1) they are outside the age range specified; (2) they are not regularly enrolled and attending school; (3) they have a history of prior or current treatment with psychoactive drugs or psychotherapy; (4) they are mentally retarded (Overall IQ<80); (5) they have a main diagnosis differing from ADHD, including children with other psychiatric or neurological diagnoses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methylphenidate	methylphenidate (Ritalin®)	-

Primary Outcome Measures

Name	Time	Method
Resting-state functional connectivity	After 6 months	After 6 months of treatment, participants will perform a second fMRI

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil