NCT01705613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

Same day

First QC Date

October 9, 2012

Last Update Submit

April 10, 2014

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity DisorderADHDMethylphenidate Immediate-releaseCost-effectivenessCost-utilityQALYs

Outcome Measures

Primary Outcomes (2)

  • Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)

    Baseline, 1th, 3rd and 6th month

  • Health Utility Index

    Baseline and 6th month

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with indication of Attention Deficit/Hyperactivity Disorder treatment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 26375808DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Luis A Rohde, MD, PhD

    Hospital de Clinicas de Porto Alegre

    STUDY CHAIR

  • Carlos R Moreira Maia, MD

    Hospital de Clinicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Luis Augusto Paim Rohde

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

April 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

BR(1)