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 has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Hospital de Clinicas de Porto Alegre
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00773916
First received: October 15, 2008
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Methylphenidate
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:


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

Primary Outcome Measures:
  • SNAP -IV scores [ Time Frame: 1, 2, 3 and 6 months of treatment ] [ Designated as safety issue: No ]
  • CGI scores [ Time Frame: 1, 2, 3 and 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores in CGAS [ Time Frame: 1, 2, 3 and 6 months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methylphenidate
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: October 15, 2008
Last Updated: August 14, 2009
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014