Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
NCT ID: NCT02951754
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
600 participants
INTERVENTIONAL
2002-02-28
2032-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IR-MPH
Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Federal University of Rio Grande do Sul
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Coordination for the Improvement of Higher Education Personnel
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Eugênio H Grevet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Eugênio H Grevet, MD, PhD
Role: primary
Claiton HD Bau, MD, PhD
Role: backup
References
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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.
Epstein T, Patsopoulos NA, Weiser M. Immediate-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2014 Sep 18;(9):CD005041. doi: 10.1002/14651858.CD005041.pub2.
Castells X, Cunill R, Capella D. Treatment discontinuation with methylphenidate in adults with attention deficit hyperactivity disorder: a meta-analysis of randomized clinical trials. Eur J Clin Pharmacol. 2013 Mar;69(3):347-56. doi: 10.1007/s00228-012-1390-7. Epub 2012 Sep 16.
Retz W, Retz-Junginger P. Prediction of methylphenidate treatment outcome in adults with attention-deficit/hyperactivity disorder (ADHD). Eur Arch Psychiatry Clin Neurosci. 2014 Nov;264 Suppl 1:S35-43. doi: 10.1007/s00406-014-0542-4. Epub 2014 Sep 18.
Steele M, Jensen PS, Quinn DM. Remission versus response as the goal of therapy in ADHD: a new standard for the field? Clin Ther. 2006 Nov;28(11):1892-908. doi: 10.1016/j.clinthera.2006.11.006.
Swanson JM, Schuck S, Porter MM, Carlson C, Hartman CA, Sergeant JA, Clevenger W, Wasdell M, McCleary R, Lakes K, Wigal T. Categorical and Dimensional Definitions and Evaluations of Symptoms of ADHD: History of the SNAP and the SWAN Rating Scales. Int J Educ Psychol Assess. 2012 Apr;10(1):51-70.
Brod M, Johnston J, Able S, Swindle R. Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006 Feb;15(1):117-29. doi: 10.1007/s11136-005-8325-z.
Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
Gomes-Oliveira MH, Gorenstein C, Lotufo Neto F, Andrade LH, Wang YP. Validation of the Brazilian Portuguese version of the Beck Depression Inventory-II in a community sample. Braz J Psychiatry. 2012 Dec;34(4):389-94. doi: 10.1016/j.rbp.2012.03.005.
Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.
Other Identifiers
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100358
Identifier Type: -
Identifier Source: org_study_id