Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Overview
- Phase
- Phase 4
- Intervention
- Immediate-release Methylphenidate
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Self-reported changes in severity of ADHD symptoms
- Status
- Recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •White Brazilian of European descent
- •Fulfillment of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) diagnostic criteria for ADHD
- •Eligibility to immediate-release MPH (IR-MPH) treatment
Exclusion Criteria
- •Contraindication for IR-MPH use
- •Current stimulant treatment
- •Evidence of a clinically significant neurological disease that might affect cognition (e.g., delirium, dementia, epilepsy, head trauma, and multiple sclerosis)
- •Current or past history of psychosis
- •Estimated intelligence quotient score lower than 70
Arms & Interventions
IR-MPH
Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control
Intervention: Immediate-release Methylphenidate
Outcomes
Primary Outcomes
Self-reported changes in severity of ADHD symptoms
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
Secondary Outcomes
- Self-reported changes in severity of oppositional defiant disorder symptoms(1yr)
- Psychiatrist's judgment of improvement of patient's symptoms(1yr)