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Clinical Trials/NCT00773916
NCT00773916
Completed
Phase 4

The Role of Adverse Environment Factors, Family Functioning and Parental Psychopathology in the Response to Treatment With Methylphenidate in Children and Adolescents With Attention Deficit/Hyperactivity Disorder

Federal University of Rio Grande do Sul1 site in 1 country130 target enrollmentMarch 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Federal University of Rio Grande do Sul
Enrollment
130
Locations
1
Primary Endpoint
SNAP -IV scores
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of this study is to investigate the association of adverse environmental factors, parental psychopathology, family functioning and genetic factors and the response to methylphenidate treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder.

Detailed Description

Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic disorder, with a worldwide estimated prevalence of 5,29%. It is associated with a high risk of functional impairment in many aspects of the patient´s life, such as academic achievements, peers relationships and physical injuries. There are few studies assessing predictive factors of clinical response to treatment. Different patterns of family functioning, such as high family conflict and low family cohesion might be associated with a poor treatment response, possibly mediating the effects of higher severity af the disorder and/or higher prevalence of comorbidity. Parental psychopathology has been associated with a poorer prognosis and is related with family functioning. Adverse social factors have long been studied and are associated with an increased risk for general mental disease, including ADHD, as well as a poorer prognosis. Different genetic factors have been studied and associated with different aspects of the disorder and different clinical responses to treatments. There are no studies evaluating how those factors interact with each other in a Brazilian population.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
July 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Federal University of Rio Grande do Sul

Eligibility Criteria

Inclusion Criteria

  • Age: 5 - 18
  • Primary Indication of Methylphenidate

Exclusion Criteria

  • Clinical conditions that preclude use of methylphenidate

Outcomes

Primary Outcomes

SNAP -IV scores

Time Frame: 1, 2, 3 and 6 months of treatment

CGI scores

Time Frame: 1, 2, 3 and 6 months of treatment

Secondary Outcomes

  • Scores in CGAS(1, 2, 3 and 6 months of treatment)

Study Sites (1)

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