Clinical trial NCT02695355: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 87
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: Classification as RE or non-RE within a time frame of five to ten weeks after onset of medication trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Pediatric Neuropsychiatric Team, Østfold Hospital Trust
Study officials:
affiliation: Ostfold Hospital Trust
name: Geir Ogrim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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