Clinical trial NCT02951754: Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Official title: Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD
Adults
treatment
Methylphenidate
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordination for the Improvement of Higher Education Personnel
First posted: 2016-11-01
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-reported changes in severity of ADHD symptoms
timeFrame: 1yr
Secondary outcomes:
measure: Self-reported changes in severity of oppositional defiant disorder symptoms
timeFrame: 1yr
measure: Psychiatrist's judgment of improvement of patient's symptoms
timeFrame: 1yr
Other outcomes:
measure: Maintenance of ADHD diagnosis
timeFrame: 1yr
measure: Changes in side effects
timeFrame: 1yr
measure: Changes in measures of anxiety
timeFrame: 1yr
measure: Changes in measures of depression
timeFrame: 1yr
measure: Changes in scores of mood disorders
timeFrame: 1yr
measure: Changes in insomnia problems
timeFrame: 1yr
measure: Changes in scores of physical activity
timeFrame: 1yr
measure: Changes in measures of quality of life
timeFrame: 1yr
measure: Changes in measures of functional impairment in the main contexts of patient's life
timeFrame: 1yr
Locations:
city: Porto Alegre
country: Brazil
facility: Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Eugênio H Grevet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faraone SV, Spencer T, Aleardi M, Pagano C, Biederman J. Meta-analysis of the efficacy of methylphenidate for treating adult attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 2004 Feb;24(1):24-9. doi: 10.1097/01.jcp.0000108984.11879.95.
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