Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Adults, treatment, Methylphenidate
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.
Interventions
DRUGImmediate-release Methylphenidate
Standard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects
Sponsors
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Hospital de Clinicas de Porto Alegre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in measures of depression | 1yr | Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment |
| Changes in scores of mood disorders | 1yr | Evaluated by Mood Disorder Questionnaire (MDQ). Assessment points at baseline, 6 months and 1 year of treatment |
| Changes in insomnia problems | 1yr | Evaluated by Insomnia Severity Index (ISI). Assessment points at baseline, 6 months and 1 year of treatment |
| Maintenance of ADHD diagnosis | 1yr | 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 |
| Changes in measures of quality of life | 1yr | Evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL). Assessment points at baseline, 6 months and 1 year of treatment |
| Changes in measures of functional impairment in the main contexts of patient's life | 1yr | Evaluated by Sheehan Disability Scale (SDS). Assessment points at baseline, 3 months, 6 months and 1 year of treatment |
| Changes in scores of physical activity | 1yr | Evaluated by International Physical Activity Questionnaires (IPAQ). Assessment points at baseline, 6 months and 1 year of treatment |
| Changes in side effects | 1yr | Evaluated by Barkley's Stimulants Side Effects Rating Scale. Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment |
| Changes in measures of anxiety | 1yr | Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment |
Countries
Brazil
Contacts
Primary ContactEugênio H Grevet, MD, PhD
Backup ContactClaiton HD Bau, MD, PhD
Outcome results
None listed