ERP Based Single-dose Predictions of Stimulants

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Pediatric Attention Deficit Hyperactivity Disorder: Predicting Clinical Response to Stimulant Medication From Single-dose Changes in Event Related Potentials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02695355
• Other study ID #: AB3330
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2016
• Last updated: February 29, 2016
• Start date: October 2006
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate (MPH)
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.

Locations

Country	Name	City	State
Norway	Pediatric Neuropsychiatric Team, Østfold Hospital Trust	Fredrikstad

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

References & Publications (11)

Barkley RA. Predicting the response of hyperkinetic children to stimulant drugs: a review. J Abnorm Child Psychol. 1976;4(4):327-48. Review. — View 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. — View 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 — View 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. — View 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. — View 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. d — View 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 — View 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 — View 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. Review. — View 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. Epub 2006 Aug 4. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No