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

Attention Deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705613
• Other study ID #: 100540
• Secondary ID: 100540U1111-1131
• Status: Completed
• Phase: N/A
• First received: October 9, 2012
• Last updated: April 10, 2014
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)		Baseline, 1th, 3rd and 6th month	No
Primary	Health Utility Index		Baseline and 6th month	No