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Trial record 27 of 439 for:    Methylphenidate

Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02951754
Recruitment Status : Recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Immediate-release Methylphenidate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Study Start Date : February 2002
Estimated Primary Completion Date : December 2032
Estimated Study Completion Date : December 2032


Arm Intervention/treatment
Experimental: IR-MPH
Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control
Drug: Immediate-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
Other Name: Ritaline




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951754


Contacts
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Contact: Eugênio H Grevet, MD, PhD +55 51 3359-8094 ehgrevet@gmail.com
Contact: Claiton HD Bau, MD, PhD +55 51 33086718 claiton.bau@gmail.com

Locations
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Brazil
Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Eugênio H Grevet, MD, PhD    +55 51 3359-8094    ehgrevet@gmail.com   
Contact: Claiton HD Bau, MD, PhD    +55 51 33086718    claiton.bau@gmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Investigators
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Principal Investigator: Eugênio H Grevet, MD, PhD Hospital de Clínicas de Porto Alegre

Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02951754     History of Changes
Other Study ID Numbers: 100358
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
ADHD
Adults
treatment
Methylphenidate
Additional relevant MeSH terms:
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Methylphenidate
Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents