Recruiting

Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

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What is being tested

Immediate-release Methylphenidate

Drug
Who is being recruted

Attention Deficit Disorder with Hyperactivity+1

+ Mental Disorders

+ Attention Deficit and Disruptive Behavior Disorders

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2002
See protocol details

Summary

Principal SponsorHospital de Clinicas de Porto Alegre
Study ContactEugênio H Grevet, MD, PhDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleMethylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
NCT02951754
Principal SponsorHospital de Clinicas de Porto Alegre
Study ContactEugênio H Grevet, MD, PhDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Attention Deficit Disorder with HyperactivityMental DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Criteria

3 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre

Porto Alegre, BrazilOpen Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre in Google Maps
Recruiting
One Study Center