Attention Deficit/Hyperactivity DisorderNCT01705613
Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil
An observational study of Attention Deficit/Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder treatment
Who may be able to join
- 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
Who cannot join
- Contraindication methylphenidate immediate release use
- Neurological diseases
- Discordance with the informed consent form
- IQ<70
- Neurological diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
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.
Read the 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.
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Attention Deficit/Hyperactivity Disorder, ADHD, Methylphenidate Immediate-release, Cost-effectiveness, Cost-utility, QALYs
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
Measured: Baseline, 1th, 3rd and 6th month
Health Utility Index
Measured: Baseline and 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, larohde, Hospital de Clinicas de Porto Alegre
- Investigators
- Luis A Rohde, MD, PhD, Study chair, Hospital de Clinicas de Porto AlegreCarlos R Moreira Maia, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705613
- Sponsor's protocol ID
- 100540
- Other IDs
- 100540, U1111-1131-1903
- Status last verified
- Apr 2014
- First submitted
- 9 Oct 2012
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maia CR, Stella SF, Wagner F, Pianca TG, Krieger FV, Cruz LN, Polanczyk GV, Rohde LA, Polanczyk CA. Cost-utility analysis of methylphenidate treatment for children and adolescents with ADHD in Brazil. Braz J Psychiatry. 2016 Mar;38(1):30-8. doi: 10.1590/1516-4446-2014-1516. Epub 2015 Sep 8.
PubMed 26375808
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of the Treatment of Attention Deficit/Hyperactivity Disorder With Methylphenidate Immediate-release in Brazil
- ClinicalTrials.gov ID
- NCT01705613
- Acronym / sponsor ID
- 100540
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Keywords
- Attention Deficit/Hyperactivity Disorder, ADHD, Methylphenidate Immediate-release, Cost-effectiveness, Cost-utility, QALYs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindication methylphenidate immediate release use
- Neurological diseases
- Discordance with the informed consent form
- IQ<70
- Neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
Time frame: Baseline, 1th, 3rd and 6th month
Health Utility Index
Time frame: Baseline and 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Derived from this study: PubMed 26375808Maia CR, Stella SF, Wagner F, Pianca TG, Krieger FV, Cruz LN, Polanczyk GV, Rohde LA, Polanczyk CA. Cost-utility analysis of methylphenidate treatment for children and adolescents with ADHD in Brazil. Braz J Psychiatry. 2016 Mar;38(1):30-8. doi: 10.1590/1516-4446-2014-1516. Epub 2015 Sep 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Rohde, MD, PhD study chair
Hospital de Clinicas de Porto Alegre
Carlos R Moreira Maia, MD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit/Hyperactivity Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) (time frame: Baseline, 1th, 3rd and 6th month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.