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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773916
• Other study ID #: 06-208
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2008
• Last updated: August 14, 2009
• Start date: March 2006
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• ADHD

• Age: 5 - 18

• Primary Indication of Methylphenidate

Exclusion Criteria:

• IQ < 70

• Clinical conditions that preclude use of methylphenidate

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate
Dose increments according to clinical evaluation, starting with 0,3 mg/kg of weight/day

Locations

Country	Name	City	State
Brazil	ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNAP -IV scores		1, 2, 3 and 6 months of treatment	No
Primary	CGI scores		1, 2, 3 and 6 months of treatment	No
Secondary	Scores in CGAS		1, 2, 3 and 6 months of treatment	No

External Links

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