NCT Number: NCT02951754
Methylphenidate (MPH) is the first-line pharmacological treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD). Nevertheless, there is considerable interindividual variability regarding the dose required, tolerability and response rates to MPH. The aim of this study is to address the clinical and genetic predictors of MPH treatment outcomes in ADHD.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Location status: Recruiting
Claiton HD Bau, MD, PhD
CONTACT
Eugênio H Grevet, MD, PhD
CONTACT
Methylphenidate (MPH) is the most prescribed psychostimulant for children and adults with Attention-Deficit/Hyperactivity Disorder (ADHD). Meta-analyses and systematic reviews have shown that MPH is safe and efficacious in attenuating the core symptoms of ADHD, promoting overall clinical improvement. However, many patients still do not show an appropriate clinical response to the MPH treatment and there is considerable interindividual variability regarding the dose required, tolerability and response rates to MPH. Therefore, it is essential to address the clinical and genetic predictors of MPH treatment outcomes in ADHD.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects
Other names: Ritaline
Time frame: 1yr
Evaluated by Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults.
Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Swanson, Nolan and Pelham Rating Scale - Version IV (SNAP-IV) adapted to adults.
Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Clinical Global Impression - Improvement scale (CGI-I). Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time frame: 1yr
Assessed by Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS).
Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Barkley's Stimulants Side Effects Rating Scale. Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Mood Disorder Questionnaire (MDQ). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Insomnia Severity Index (ISI). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by International Physical Activity Questionnaires (IPAQ). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL). Assessment points at baseline, 6 months and 1 year of treatment
Time frame: 1yr
Evaluated by Sheehan Disability Scale (SDS). Assessment points at baseline, 3 months, 6 months and 1 year of treatment
Contact information is provided by the study sponsor or research team.
Claiton HD Bau, MD, PhD
CONTACT
Eugênio H Grevet, MD, PhD
CONTACT
Hospital de Clinicas de Porto Alegre
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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