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Clinical Trials/NCT00773916
NCT00773916CompletedPhase 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 Sul2 sites in 1 country130 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
130
Locations
2
Primary Endpoint
SNAP -IV scores

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
5 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Federal University of Rio Grande do Sul
Sponsor Class
Other

Study Sites (2)

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