Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02951754
• Other study ID #: 100358
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2016
• Last updated: October 31, 2016
• Start date: February 2002
• Est. completion date: December 2032

Study information

• Verified date: October 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Eugênio H Grevet, MD, PhD
• Phone: +55 51 3359-8094
• Email: ehgrevet[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2032
• Est. primary completion date: December 2032
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Disease
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Brazil	Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel, Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View Citation

Castells X, Cunill R, Capellà 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. Review. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2016;(5):CD005041. — View 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. — View Citation

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. Rev Bras Psiquiatr. 2012 Dec;34(4):389-94. — View Citation

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. — View Citation

Morin CM, Belleville G, Bélanger 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maintenance of ADHD diagnosis	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	1yr	No
Other	Changes in side effects	Evaluated by Barkley's Stimulants Side Effects Rating Scale. Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment	1yr	No
Other	Changes in measures of anxiety	Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in measures of depression	Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in scores of mood disorders	Evaluated by Mood Disorder Questionnaire (MDQ). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in insomnia problems	Evaluated by Insomnia Severity Index (ISI). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in scores of physical activity	Evaluated by International Physical Activity Questionnaires (IPAQ). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in measures of quality of life	Evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL). Assessment points at baseline, 6 months and 1 year of treatment	1yr	No
Other	Changes in measures of functional impairment in the main contexts of patient's life	Evaluated by Sheehan Disability Scale (SDS). Assessment points at baseline, 3 months, 6 months and 1 year of treatment	1yr	No
Primary	Self-reported changes in severity of ADHD symptoms	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	1yr	No
Secondary	Self-reported changes in severity of oppositional defiant disorder symptoms	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	1yr	No
Secondary	Psychiatrist's judgment of improvement of patient's symptoms	Evaluated by Clinical Global Impression - Improvement scale (CGI-I). Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment	1yr	No