Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

Hospital de Clinicas de Porto Alegre

Status and phase: Enrolling; Phase 4

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Immediate-release Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT02951754

100358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

IR-MPH

Experimental group

Description:

Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control

Treatment:

Drug: Immediate-release Methylphenidate