Back to resultsCost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
Primary Purpose
Attention-deficit/Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
methylphenidate (Ritalin®)
Sponsored by
About this trial
This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder focused on measuring open label, Ritalin®, ADHD
Eligibility Criteria
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
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Methylphenidate
Arm Description
Outcomes
Primary Outcome Measures
Resting-state functional connectivity
After 6 months of treatment, participants will perform a second fMRI
Secondary Outcome Measures
Full Information
NCT ID
NCT01228604
First Posted
October 22, 2010
Last Updated
July 17, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01228604
Brief Title
Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
Official Title
COST-EFFECTIVENESS STUDY OF THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER IN BRAZIL
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder
Keywords
open label, Ritalin®, ADHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methylphenidate (Ritalin®)
Intervention Description
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,
Primary Outcome Measure Information:
Title
Resting-state functional connectivity
Description
After 6 months of treatment, participants will perform a second fMRI
Time Frame
After 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
We'll reach out to this number within 24 hrs