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Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Recruiting
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Immediate-release Methylphenidate
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Adults, treatment, Methylphenidate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IR-MPH

Arm Description

Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 31, 2016
Last Updated
October 31, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
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1. Study Identification

Unique Protocol Identification Number
NCT02951754
Brief Title
Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Official Title
Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Recruiting
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2032 (Anticipated)
Study Completion Date
December 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
ADHD, Adults, treatment, Methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IR-MPH
Arm Type
Experimental
Arm Description
Immediate-release methylphenidate (IR-MPH) 10 mg two or three times daily with doses increasing weekly until symptom control
Intervention Type
Drug
Intervention Name(s)
Immediate-release Methylphenidate
Other Intervention Name(s)
Ritaline
Intervention Description
Standard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects
Primary Outcome Measure Information:
Title
Self-reported changes in severity of ADHD symptoms
Description
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
Time Frame
1yr
Secondary Outcome Measure Information:
Title
Self-reported changes in severity of oppositional defiant disorder symptoms
Description
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
Time Frame
1yr
Title
Psychiatrist's judgment of improvement of patient's symptoms
Description
Evaluated by Clinical Global Impression - Improvement scale (CGI-I). Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time Frame
1yr
Other Pre-specified Outcome Measures:
Title
Maintenance of ADHD diagnosis
Description
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
Time Frame
1yr
Title
Changes in side effects
Description
Evaluated by Barkley's Stimulants Side Effects Rating Scale. Assessment points at baseline, 6 weeks, 3 months, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in measures of anxiety
Description
Evaluated by Beck Anxiety Inventory (BAI). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in measures of depression
Description
Evaluated by Beck Depression Inventory (BDI). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in scores of mood disorders
Description
Evaluated by Mood Disorder Questionnaire (MDQ). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in insomnia problems
Description
Evaluated by Insomnia Severity Index (ISI). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in scores of physical activity
Description
Evaluated by International Physical Activity Questionnaires (IPAQ). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in measures of quality of life
Description
Evaluated by Adult ADHD Quality of Life Questionnaire (AAQoL). Assessment points at baseline, 6 months and 1 year of treatment
Time Frame
1yr
Title
Changes in measures of functional impairment in the main contexts of patient's life
Description
Evaluated by Sheehan Disability Scale (SDS). Assessment points at baseline, 3 months, 6 months and 1 year of treatment
Time Frame
1yr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugênio H Grevet, MD, PhD
Phone
+55 51 3359-8094
Email
ehgrevet@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claiton HD Bau, MD, PhD
Phone
+55 51 33086718
Email
claiton.bau@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugênio H Grevet, MD, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Program on Attention-Deficit/Hyperactivity Disorder (PRODAH); Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugênio H Grevet, MD, PhD
Phone
+55 51 3359-8094
Email
ehgrevet@gmail.com
First Name & Middle Initial & Last Name & Degree
Claiton HD Bau, MD, PhD
Phone
+55 51 33086718
Email
claiton.bau@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
14709943
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. doi: 10.1097/01.jcp.0000108984.11879.95.
Results Reference
background
PubMed Identifier
25230710
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.
Results Reference
background
PubMed Identifier
22983311
Citation
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.
Results Reference
background
PubMed Identifier
25231833
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. Epub 2014 Sep 18.
Results Reference
background
PubMed Identifier
17213010
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. doi: 10.1016/j.clinthera.2006.11.006.
Results Reference
background
PubMed Identifier
26504617
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.
Results Reference
background
PubMed Identifier
16411036
Citation
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.
Results Reference
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PubMed Identifier
21532953
Citation
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.
Results Reference
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PubMed Identifier
23429809
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. Braz J Psychiatry. 2012 Dec;34(4):389-94. doi: 10.1016/j.rbp.2012.03.005.
Results Reference
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PubMed Identifier
8736107
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.
Results Reference
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Methylphenidate in Adults With Attention Deficit/Hyperactivity Disorder

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