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Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil

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ClinicalTrials.gov Identifier: NCT01705613
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : April 14, 2014
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
larohde, Hospital de Clinicas de Porto Alegre

Brief Summary:

The first objective is to measure the QALYs (Quality Adjusted Life Years) of Brazilian children and adolescents, submitted to methylphenidate immediate-release treatment for Attention Deficit Hyperactivity Disorder (ADHD). For this, the Health Utility Index scale (HUI) will be completed by the patient and/or family, in two moments of an observation study with immediate-release methylphenidate: at the baseline and 6th month of treatment in the follow-up. The results provides information to calculate the utility measure and determine the QALYs (Quality Adjusted Life Years). After this, for the cost-effectiveness of the treatment, it will be used a Markov model of decision analysis, and a Monte Carlo simulation with 10,000 random trials.

Subjects will be submitted to immediate-release methylphenidate treatment in a maximum dose of 0.5mg/kg/day. The total treatment monitoring is 06 (six) months, and patients will be evaluated at baseline, first, third and sixth month. The HUI rating scales are fulfilled by parents and patients (if >12 years old only) at baseline and 6th month. The period for inclusion of new patients comprises from 01/01/2011 to 31/12/2013.


Condition or disease
Attention Deficit/Hyperactivity Disorder

Detailed Description:

Currently, Brazil has no estimates for quality of life, and/or utilities for ADHD economy analysis. Such data is necessary to calculate the QALYs (Quality Adjusted Life Years). Thus, the investigators will implement the Health Utility Index tool (HUI) to be completed by the patient and/or family, in two moments of an observational study with immediate-release methylphenidate: at baseline and 6th month of treatment. The determination of the QALY as an outcome in the decision analysis is justified because HUI incorporates into a single measure morbidity and mortality. The results of the cost-effectiveness study will assist government agencies in the process of decision making.

To determine the cost-effectiveness of methylphenidate immediate release available in the Brazilian market, the investigators will use a Markov model of decision analysis. The development of the model and analysis of the results will adopt the standards established in the Methodological Guidelines of the Brazilian Ministry of Health, and the perspective will be of the Brazilian National Health System. Medications prices will be obtained through the Board of Market Regulation of Medicines (CMED) at the site of ANVISA (National Health Surveillance Agency). For the treatment strategy that provides greatest cost ratio it will be calculated the incremental cost-effectiveness, compared to the lower cost. To estimate more accurately the impact on life, a Monte Carlo simulation with 10,000 random trials will be conducted.

This is a one treatment group and observational study, with 140 patients, and no controls. Where indicated, it will be suggested the use of 10 mg methylphenidate in a maximum dose of 0.5 mg / kg / day. The total treatment monitoring is 06 (six) months, and patients will be evaluated at baseline, first, third and sixth month. The HUI rating scales will be fulfilled by parents and patients (if >12 years old only) at baseline and 6th month. The period for inclusion of new patients comprises from 01/01/2011 to 31/12/2013.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil
Study Start Date : April 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014





Primary Outcome Measures :
  1. Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) [ Time Frame: Baseline, 1th, 3rd and 6th month ]
  2. Health Utility Index [ Time Frame: Baseline and 6th month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder treatment
Criteria

Inclusion Criteria:

  • Symptoms of attention deficit/hyperactivity disorder with impairment
  • Children and adolescents (age from 06 to 18 years old)
  • absence of contraindication for the use of methylphenidate immediate release

Exclusion Criteria:

  • Contraindication methylphenidate immediate release use
  • Neurological diseases
  • Discordance with the informed consent form
  • IQ<70
  • Neurological diseases

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): NCT01705613


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Study Chair: Luis A Rohde, MD, PhD Hospital de Clinicas de Porto Alegre
Principal Investigator: Carlos R Moreira Maia, MD Hospital de Clinicas de Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: larohde, Luis Augusto Paim Rohde, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01705613     History of Changes
Other Study ID Numbers: 100540
100540 ( Other Identifier: Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre (CEP/HCPA) )
U1111-1131-1903 ( Other Identifier: Universal Trial Number )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014
Keywords provided by larohde, Hospital de Clinicas de Porto Alegre:
Attention Deficit/Hyperactivity Disorder
ADHD
Methylphenidate Immediate-release
Cost-effectiveness
Cost-utility
QALYs
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
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