Status:
COMPLETED
Cost-Effectiveness Study Of The Treatment Of Attention Deficit/Hyperactivity Disorder In Brazil
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Attention-deficit/Hyperactivity Disorder
Eligibility:
MALE
8-10 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01228604
Start Date
December 1 2010
End Date
December 1 2013
Last Update
July 21 2014
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903