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

This study is currently recruiting participants.

Verified by Federal University of Rio Grande do Sul, October 2008

Sponsors and Collaborators:	Federal University of Rio Grande do Sul Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Hospital de Clinicas de Porto Alegre
Information provided by:	Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT00773916

Purpose

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

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Methylphenidate	Phase IV

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Uncontrolled, Single Group Assignment

Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:

Parental Psychopathology - SCID [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Family Functioning - Family Environment Scale [ Time Frame: Baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
Psychosocial Adversity Measurements [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADHD symptomatology (SNAP-IV) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Scores in CGI [ Time Frame: Baseline, 1, 2, 3 and 6 months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	March 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ADHD
Age: 5 - 18
Primary Indication of Methylphenidate

Exclusion Criteria:

IQ < 70
Clinical conditions that preclude use of methylphenidate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773916

Contacts

Contact: Rodrigo Chazan, MD

51 2101 8094

cfpaim@hcpa.ufrgs.br

Locations

Brazil, Rio Grande do Sul
ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre	Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Rodrigo Chazan, MD 51 2101 8094 cfpaim@hcpa.ufrgs.br

Sponsors and Collaborators

Federal University of Rio Grande do Sul

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Hospital de Clinicas de Porto Alegre

Investigators

Principal Investigator:

Luis A Rohde, MD

Federal University of Rio Grande do Sul

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Federal University of Rio Grande do Sul ( Luis Augusto Rohde MD )
Study ID Numbers:	06-208
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773916
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:

Attention Deficit Disorder
Attention Deficit Disorders with Hyperactivity
Hyperkinetic Syndrome

Family Function
Adverse Factors
Parental Psychopathology

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs

Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009