Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
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Purpose
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 and/or neuropsychological processes. Children with ADHD will be further classified according to reading skills, and treatment effects on reading ability will also be evaluated. Additionally, this will be the first Brazilian study to assess the cost-effectiveness of the treatment of ADHD
| Condition | Intervention | Phase |
|---|---|---|
|
Attention-deficit/Hyperactivity Disorder |
Drug: methylphenidate (Ritalin®) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | COST-EFFECTIVENESS STUDY OF THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER IN BRAZIL |
- Assessment of the cost-effectiveness of the main pharmacological strategy used for treatment of ADHD in Brazil [ Time Frame: The final outcome will be after 12 months of follow-up of the subject ] [ Designated as safety issue: No ]After 12 months of treatment, participants will be recontacted for the final assessment related to the cost-effectiveness measures of the treatment.
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
-
Drug: methylphenidate (Ritalin®)
Eligibility| Ages Eligible for Study: | 8 Years to 10 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The study will include 50 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 + dyslexia 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; (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
Contacts and Locations| Contact: Luis Rohde, Doctor | 55-5133598094 | larohde@hcpa.ufrgs.br |
| Brazil | |
| Hospital de Clinicas de Porto Alegre | Recruiting |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035903 | |
| Contact: Luis Rohde, MD, PhD =55-5133598094 larohde@hcpa.ufrgs.br | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Luiz Augusto Paim Rohde, Hospital de Clínicas de Porto Alegre |
| ClinicalTrials.gov Identifier: | NCT01228604 History of Changes |
| Other Study ID Numbers: | 100021 |
| Study First Received: | October 22, 2010 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: National Health Surveillance Agency Brazil: Ministry of Health |
Keywords provided by Hospital de Clinicas de Porto Alegre:
|
open label Ritalin® ADHD |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Methylphenidate |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013