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Completed

NCT Number: NCT02695355

ERP Based Single-dose Predictions of Stimulants

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).

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Neuropsychiatric Team, Østfold Hospital Trust

Fredrikstad, 1605, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ritalin tablets

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

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

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2013
Study completion
2015
First posted
Mar 1, 2016
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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