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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

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ClinicalTrials.gov Identifier: NCT00773916
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : August 17, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate Phase 4

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  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Study Start Date : March 2006
Primary Completion Date : July 2008
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. SNAP -IV scores [ Time Frame: 1, 2, 3 and 6 months of treatment ]
  2. CGI scores [ Time Frame: 1, 2, 3 and 6 months of treatment ]

Secondary Outcome Measures :
  1. Scores in CGAS [ Time Frame: 1, 2, 3 and 6 months of treatment ]

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773916


Locations
Brazil
ADHD Outpatient Program - Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Luis A Rohde, MD Federal University of Rio Grande do Sul
More Information

Additional Information:
Responsible Party: Luis Augusto Rohde MD, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00773916     History of Changes
Other Study ID Numbers: 06-208
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: August 17, 2009
Last Verified: August 2009

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

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents