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

NCT01228604 | Completed Phase 4

• 1 other identifier: 100021
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

open label; Ritalin®; ADHD

Outcome Measures

Primary Outcomes (1)

• Resting-state functional connectivity

  After 6 months of treatment, participants will perform a second fMRI

  After 6 months

Study Arms (1)

Methylphenidate

EXPERIMENTAL

Drug: methylphenidate (Ritalin®)

Interventions

methylphenidate (Ritalin®) DRUG

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,

Methylphenidate

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 26, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

BR (1)