Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

Phase 4

Recruiting

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Immediate-release Methylphenidate

• Registration Number: NCT02951754
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2002-02
• Status Verified: 2016-10
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Last Update Submitted: 2016-10-31
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01
• Primary Completion: 2032-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Self-reported changes in severity of ADHD symptoms	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 Outcome Measures

Name	Time	Method
Self-reported changes in severity of oppositional defiant disorder symptoms	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
Psychiatrist's judgment of improvement of patient's symptoms	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

Trial Locations

Locations (1)

Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil