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NCT Number: NCT02951754

Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate-release Methylphenidate

Drug

Standard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects

Other names: Ritaline

Primary outcomes

  1. Self-reported changes in severity of ADHD symptoms

    Time frame: 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 outcomes

  1. Self-reported changes in severity of oppositional defiant disorder symptoms

    Time frame: 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

  2. Psychiatrist's judgment of improvement of patient's symptoms

    Time frame: 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 outcomes

  1. Maintenance of ADHD diagnosis

    Time frame: 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

  2. Changes in side effects

    Time frame: 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

  3. Changes in measures of anxiety

    Time frame: 1yr

    Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment

  4. Changes in measures of depression

    Time frame: 1yr

    Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment

  5. Changes in scores of mood disorders

    Time frame: 1yr

    Evaluated by Mood Disorder Questionnaire (MDQ). Assessment points at baseline, 6 months and 1 year of treatment

  6. Changes in insomnia problems

    Time frame: 1yr

    Evaluated by Insomnia Severity Index (ISI). Assessment points at baseline, 6 months and 1 year of treatment

  7. Changes in scores of physical activity

    Time frame: 1yr

    Evaluated by International Physical Activity Questionnaires (IPAQ). Assessment points at baseline, 6 months and 1 year of treatment

  8. Changes in measures of quality of life

    Time frame: 1yr

    Evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL). Assessment points at baseline, 6 months and 1 year of treatment

  9. Changes in measures of functional impairment in the main contexts of patient's life

    Time frame: 1yr

    Evaluated by Sheehan Disability Scale (SDS). Assessment points at baseline, 3 months, 6 months and 1 year of treatment

Interested in participating?

Recruiting

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Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel
  • Federal University of Rio Grande do Sul

Registry information

Important dates

Study start
2002
Primary completion
2032
Study completion
2032
First posted
Nov 1, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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