NCT02695355

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

6.3 years

First QC Date

February 15, 2016

Last Update Submit

February 29, 2016

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.

Study Arms (1)

ADHD medication effects

EXPERIMENTAL

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

Drug: Methylphenidate (MPH)

Interventions

Methylphenidate (MPH)DRUG

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.

Also known as: Ritalin tablets
ADHD medication effects

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Neuropsychiatric Team, Østfold Hospital Trust

Fredrikstad, 1605, Norway

Location

Related Publications (13)

  • 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.

    PMID: 24043939RESULT

  • 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.

    PMID: 24523588RESULT

  • 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.

    PMID: 16041867RESULT

  • 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.

    PMID: 25237119RESULT

  • 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.

    PMID: 794087RESULT

  • 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.

    PMID: 10385840RESULT

  • 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.

    PMID: 11514638RESULT

  • 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.

    PMID: 16890481RESULT

  • 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.

    PMID: 7893855RESULT

  • 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.

    PMID: 23660970RESULT

  • 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.

    PMID: 21597989RESULT

  • 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.

    PMID: 29940782DERIVED

  • 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.

    PMID: 29476840DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Geir Ogrim, PhD

    Ostfold Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

March 1, 2016

Study Start

October 1, 2006

Primary Completion

January 1, 2013

Study Completion

September 1, 2015

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)