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ERP Based Single-dose Predictions of Stimulants

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Methylphenidate (MPH)
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients referred to the clinic diagnosed with Attention Deficit Hyperactivity Disorder. Cases With comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included.

Exclusion Criteria:

  • Patients With intelligence coefficients below 70 or a diagnosed neurological disease are excluded.

Sites / Locations

  • Pediatric Neuropsychiatric Team, Østfold Hospital Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADHD medication effects

Arm Description

Single dose methylphenidate (Ritalin tablets); 10 mg for ages 8-13; 15 mg for ages 13-17

Outcomes

Primary Outcome Measures

Classification as responders (REs) or non-responders (non-REs) based on daily ratings from parents and teachers of ADHD symptoms during a four weeks medication trial

Secondary Outcome Measures

Full Information

First Posted
February 15, 2016
Last Updated
February 29, 2016
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02695355
Brief Title
ERP Based Single-dose Predictions of Stimulants
Official Title
Pediatric Attention Deficit Hyperactivity Disorder: Predicting Clinical Response to Stimulant Medication From Single-dose Changes in Event Related Potentials
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to see if the clinical outcome of stimulant medication (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the performance of an attention task).
Detailed Description
In the pediatric neuropsychiatric clinic of Ostfold Hospital Trust, Norway, patients diagnosed with attention deficit hyperactivity disorder are tested with quantitative EEG (QEEG) and ERPs to supplement the neuropsychological examination. In the majority of cases a systematic four weeks trial on stimulant medication is offered, and the clinical effects are evaluated at the end of the try-out period. This procedure is a clinical routine. In this study patients and parents were asked if they were willing to complete a second QEEG/ERP test on a single dose of stimulant medication shortly before the onset of the four weeks trial. They were explained that the aim of the study was to search for predictors of clinical response. They were also informed that this second test was completely voluntary. (In fact the vast majority were quite enthusiastic). The patients were characterized as responders (REs - medication continued) or non-responders (non-REs - medication stopped) based on explicit criteria. The single-dose induced changes in ERPs (and behavioral parameters from the attention test; number of errors, reaction times) were examined, and differences between REs and non-REs were calculated. If the analysis of data show that one or several variables are significantly different in REs and non-REs with large effect sizes, these findings may eventually result in the development of a useful clinical tool.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADHD medication effects
Arm Type
Experimental
Arm Description
Single dose methylphenidate (Ritalin tablets); 10 mg for ages 8-13; 15 mg for ages 13-17
Intervention Type
Drug
Intervention Name(s)
Methylphenidate (MPH)
Other Intervention Name(s)
Ritalin tablets
Intervention Description
Test 1: No medication. Registration of ERPs and behavioral data during an attention task. Test 2: Test repeated on a single dose of MPH. Outcome measure: Classification as responders or non-responders after a four weeks medication trial, based on rating scales from parents and Teachers.
Primary Outcome Measure Information:
Title
Classification as responders (REs) or non-responders (non-REs) based on daily ratings from parents and teachers of ADHD symptoms during a four weeks medication trial
Time Frame
Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred to the clinic diagnosed with Attention Deficit Hyperactivity Disorder. Cases With comorbid diagnoses such as emotional or behavioral disorders, learning disabilities or high functioning autism are included. Exclusion Criteria: Patients With intelligence coefficients below 70 or a diagnosed neurological disease are excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Ogrim, PhD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Neuropsychiatric Team, Østfold Hospital Trust
City
Fredrikstad
ZIP/Postal Code
1605
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24043939
Citation
Ogrim G, Hestad KA, Brunner JF, Kropotov J. Predicting acute side effects of stimulant medication in pediatric attention deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a continuous-performance test. Neuropsychiatr Dis Treat. 2013;9:1301-9. doi: 10.2147/NDT.S49611. Epub 2013 Sep 5.
Results Reference
result
PubMed Identifier
24523588
Citation
Ogrim G, Kropotov J, Brunner JF, Candrian G, Sandvik L, Hestad KA. Predicting the clinical outcome of stimulant medication in pediatric attention-deficit/hyperactivity disorder: data from quantitative electroencephalography, event-related potentials, and a go/no-go test. Neuropsychiatr Dis Treat. 2014 Feb 3;10:231-42. doi: 10.2147/NDT.S56600. eCollection 2014.
Results Reference
result
PubMed Identifier
16041867
Citation
Hermens DF, Cooper NJ, Kohn M, Clarke S, Gordon E. Predicting stimulant medication response in ADHD: evidence from an integrated profile of neuropsychological, psychophysiological and clinical factors. J Integr Neurosci. 2005 Mar;4(1):107-21. doi: 10.1142/s0219635205000653.
Results Reference
result
PubMed Identifier
25237119
Citation
Johnston BA, Coghill D, Matthews K, Steele JD. Predicting methylphenidate response in attention deficit hyperactivity disorder: a preliminary study. J Psychopharmacol. 2015 Jan;29(1):24-30. doi: 10.1177/0269881114548438. Epub 2014 Sep 18.
Results Reference
result
PubMed Identifier
794087
Citation
Barkley RA. Predicting the response of hyperkinetic children to stimulant drugs: a review. J Abnorm Child Psychol. 1976;4(4):327-48. doi: 10.1007/BF00922531.
Results Reference
result
PubMed Identifier
10385840
Citation
Chabot RJ, Orgill AA, Crawford G, Harris MJ, Serfontein G. Behavioral and electrophysiologic predictors of treatment response to stimulants in children with attention disorders. J Child Neurol. 1999 Jun;14(6):343-51. doi: 10.1177/088307389901400601.
Results Reference
result
PubMed Identifier
11514638
Citation
Riccio CA, Waldrop JJ, Reynolds CR, Lowe P. Effects of stimulants on the continuous performance test (CPT): implications for CPT use and interpretation. J Neuropsychiatry Clin Neurosci. 2001 Summer;13(3):326-35. doi: 10.1176/jnp.13.3.326.
Results Reference
result
PubMed Identifier
16890481
Citation
Sangal RB, Sangal JM. Attention-deficit/hyperactivity disorder: use of cognitive evoked potential (P300) to predict treatment response. Clin Neurophysiol. 2006 Sep;117(9):1996-2006. doi: 10.1016/j.clinph.2006.06.004. Epub 2006 Aug 4.
Results Reference
result
PubMed Identifier
7893855
Citation
Young ES, Perros P, Price GW, Sadler T. Acute challenge ERP as a prognostic of stimulant therapy outcome in attention-deficit hyperactivity disorder. Biol Psychiatry. 1995 Jan 1;37(1):25-33. doi: 10.1016/0006-3223(94)00075-E.
Results Reference
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PubMed Identifier
23660970
Citation
Czerniak SM, Sikoglu EM, King JA, Kennedy DN, Mick E, Frazier J, Moore CM. Areas of the brain modulated by single-dose methylphenidate treatment in youth with ADHD during task-based fMRI: a systematic review. Harv Rev Psychiatry. 2013 May-Jun;21(3):151-62. doi: 10.1097/HRP.0b013e318293749e.
Results Reference
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PubMed Identifier
21597989
Citation
Linssen AM, Vuurman EF, Sambeth A, Nave S, Spooren W, Vargas G, Santarelli L, Riedel WJ. Contingent negative variation as a dopaminergic biomarker: evidence from dose-related effects of methylphenidate. Psychopharmacology (Berl). 2011 Dec;218(3):533-42. doi: 10.1007/s00213-011-2345-x. Epub 2011 May 20.
Results Reference
result
PubMed Identifier
29940782
Citation
Ogrim G, Kropotov JD. Predicting Clinical Gains and Side Effects of Stimulant Medication in Pediatric Attention-Deficit/Hyperactivity Disorder by Combining Measures From qEEG and ERPs in a Cued GO/NOGO Task. Clin EEG Neurosci. 2019 Jan;50(1):34-43. doi: 10.1177/1550059418782328. Epub 2018 Jun 25.
Results Reference
derived
PubMed Identifier
29476840
Citation
Aasen IE, Ogrim G, Kropotov J, Brunner JF. Methylphenidate selectively modulates one sub-component of the no-go P3 in pediatric ADHD medication responders. Biol Psychol. 2018 Apr;134:30-38. doi: 10.1016/j.biopsycho.2018.02.011. Epub 2018 Feb 21.
Results Reference
derived

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ERP Based Single-dose Predictions of Stimulants

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