Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital de Clinicas de Porto Alegre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Immediate-release Methylphenidate
DrugStandard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: IR-MPHExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported changes in severity of ADHD symptoms
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
1yrSecondary outcomes
1
Self-reported changes in severity of oppositional defiant disorder symptoms
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
1yr2
Psychiatrist's judgment of improvement of patient's symptoms
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
1yrOther outcomes
1
Maintenance of ADHD diagnosis
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
1yr2
Changes in side effects
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
1yr3
Changes in measures of anxiety
Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment
Time frame
1yr4
Changes in measures of depression
Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment
Time frame
1yrSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital de Clinicas de Porto Alegre
Lead sponsor
Federal University of Rio Grande do Sul
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Coordination for the Improvement of Higher Education Personnel
Collaborator
Source ClinicalTrials.gov