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Event Rate and Effects of Stimulants in ADHD (ERESA)

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ClinicalTrials.gov Identifier: NCT01913912
Recruitment Status : Unknown
Verified December 2014 by University Ghent.
Recruitment status was:  Not yet recruiting
First Posted : August 1, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
Fund for Scientific Research, Flanders, Belgium
Shire
Information provided by (Responsible Party):
University Ghent

Brief Summary:

Stimulants alleviate information processing and task performance deficits in Attention Deficit/Hyperactivity Disorder (ADHD). Long acting formulations of amphetamines such as lisdexamphetamine dimesylate (LDX) are especially valuable as they target the school day and improve classroom performance. Although stimulants have been widely used in treatment of ADHD, the exact mechanism action and effect on task performance is not completely known.

According to the State Regulation Deficit (SRD) model, children with ADHD have difficulty regulating their levels of arousal/activation during tasks in response to the changing demands of the environment. This leads to problems with downregulating overaroused states and upregulating underaroused states. According to this view, stimulants exert their therapeutic effect (in part) by optimising arousal/activation levels - especially during states of underarousal/activation. Arousal/activation levels can also be altered by extrinsic factors such as event rate (ER), e.g., the rate at which information is presented. Multiple studies suggest that very fast and very slow events can both cause problems for individuals with ADHD, related to overarousal and underarousal state respectively. Putting these intrinsic (stimulants) and extrinsic (ERs) factors together leads to the prediction that changing the rate at which information is presented in a task may alter the efficacy of stimulants and affect the optimal stimulant dose level. More specifically, one dose of stimulant that may be optimal on slow ER tasks (as it increases arousal/activation level) may be less effective under high ER tasks because in such a setting arousal/activation level needs to be lowered and not increased further. Adding stimulants to an already overactivated state may exacerbate the associated problems. The implication of this is that a different dose of stimulant will be needed under different environmental conditions for optimal performance. For example, children with ADHD might require different dosage in the classroom setting to optimize performance. In addition, the neuropsychological basis of performance deficits and improvement by ER and stimulants are also unclear. According to the SRD model, the underlying mechanism can be specific problems in motor activation/preparation or effort regulation. Event-related potentials (ERP), pupil size measurements and cardiac measures enable us to see objectively how motor activation/preparation and effort are affected by ER and simulants.

In this study the investigators aim to test these predictions of the SRD model and identify the neurobiological basis of stimulant action.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: LDX. Drug: sugar pill Device: computer task (Go/No-Go task) Device: EEG Device: pupil size measurements (by using eye tracking) Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Can Changing the Rate at Which Information is Presented Alter the Effects of Stimulants on ADHD Information Processing. Testing a Prediction of the State Regulation Deficit Model.
Study Start Date : January 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lisdexamfetamine dimesylate (LDX)
Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the optimal dose of LDX will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking LDX at the DRUG unit.
Drug: LDX.

In this study 3 different doses of LDX will be used:

  • 30 mg capsules: 30 mg LDX, equivalent to 8.9 mg of dexamphetamine
  • 50 mg capsules: 50 mg LDX, equivalent to 14.8 mg of dexamphetamine
  • 70 mg capsules: 70 mg LDX, equivalent to 20.8 mg of dexamphetamine
Other Name: The European brandname is Elvance®

Device: computer task (Go/No-Go task)
Device: EEG
event-related potentials (ERP) and heart rate measurements

Device: pupil size measurements (by using eye tracking)
Placebo Comparator: Sugar pill
Children will continue their therapeutic dose of LDX during the DBPC phase (which is determined during the titration phase). Before each testing session there will be a washout period of at least 48 hours; the placebo will be given the morning of the testing at the DRUG unit. For blinding purpose we will blindfold the children when taking placebo at the DRUG unit.
Drug: sugar pill
Children will take once only a placebo capsule during the DBPC phase (phase 4) the morning of the testing. For blinding purpose we will blindfold the children when taking placebo.
Other Name: placebo

Device: computer task (Go/No-Go task)
Device: EEG
event-related potentials (ERP) and heart rate measurements

Device: pupil size measurements (by using eye tracking)



Primary Outcome Measures :
  1. Performance data (by using computerized Go-No Go task) [ Time Frame: 2 weeks (week 8-9 of the study) ]
    • mean reaction time (RT)
    • standard deviation of reaction time (SDRT)
    • errors of omissions (%EoO)
    • errors of commission (%EoC)

  2. psychophysiological data [ Time Frame: 2 weeks (week 8-9 of the study) ]
    • cardiac indices: heart rate variability (HRV), heart rate deviation (HRD) (by using EEG)
    • electrophysiological indices: P3, LRP (lateralized readiness potential) (by using EEG)
    • pupil size (by using eye-tracking)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with ADHD (male and female)
  • Age: form 7 years old until the end of 12 years old at screening
  • Official diagnosis of ADHD (one of the three subtypes) as confirmed by administration of the Diagnostic Interview Scale for Children for DSM-IV (DISC-IV) interview at screening
  • No prior use of stimulant medication (Drug naïve)

Exclusion Criteria:

  • Comorbid disorders (severe anxiety or mood disorder, Autism Spectrum Disorder, Conduct disorder, Tic disorder, other major psychiatric pathologies)
  • Other neurological disorder or chronic illness/disability
  • Intelligence quotient (IQ) below 80
  • Body weight below 22.7 kg
  • Use of a psychoactive medication (especially use of monoamine oxidase inhibitors (MAOI))
  • History of cardiac disease, family history of premature (sudden/unexpected) death in children or young adults, hypertrophic cardiomyopathy, clinically important arrhythmias including long QT syndrome (LQTS), Marfan syndrome
  • Abnormal findings on physical examination indicating cardiac disease
  • Glaucoma
  • Sensitive or allergic to stimulants or other ingredients of LDX

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913912


Contacts
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Contact: Herbert Roeyers, PhD +32 (0)9 264 64 48 Herbert.Roeyers@Ugent.be

Locations
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Belgium
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Rudy Van Coster, MD, PhD       rudy.vancoster@ugent.be   
Principal Investigator: Rudy Van Coster, MD, PhD         
Ghent University Hospital Not yet recruiting
Ghent, Belgium, 9000
Contact: Luc Van Bortel, MD, PhD    +32 (0)9 3320000      
Principal Investigator: Luc Van Bortel, MD, PhD         
Ghent University Not yet recruiting
Ghent, Belgium, 9000
Contact: Herbert Roeyers, PhD    +32 (0)9 264 64 48    Herbert.Roeyers@Ugent.be   
Principal Investigator: Herbert Roeyers, PhD         
Sub-Investigator: Baris Metin, PhD         
Sub-Investigator: Roos Gasthuys, PhD         
Sponsors and Collaborators
University Ghent
Fund for Scientific Research, Flanders, Belgium
Shire
Investigators
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Principal Investigator: Rudy van Coster, MD, PhD University Hospital, Ghent
Principal Investigator: Herbert Roeyers, PhD University Ghent
Principal Investigator: Edmund Sonuga-Barke, PhD University Ghent

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01913912     History of Changes
Other Study ID Numbers: EC/2013/481
2013-001530-18 ( EudraCT Number )
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs