Status:

COMPLETED

Language & Cognitive Control

Lead Sponsor:

Donders Centre for Cognitive Neuroimaging

Collaborating Sponsors:

Max Planck Institute for Psycholinguistics

Radboud University Medical Center

Conditions:

Language

Methylphenidate of Undetermined Intent

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief Summary

Catecholamine (CA) neurotransmitters, such as dopamine (DA) and noradrenaline (NA), have long been implicated playing a critical role in cognitive functions, such as working memory (WM), inhibition, l...

Eligibility Criteria

Inclusion

  • Native Dutch speakers
  • Right-handed

Exclusion

  • Current (or history of) psychiatric disorder (e.g., psychosis, mania, severe depressive disorder)
  • Current (or history of) neurological disorder (e.g. m. Parkinson, epilepsy)
  • Current (or history of) endocrine / metabolic disorder
  • Current (or history of) cardiac or vascular disorder
  • Current (or history of) blood illness (e.g. severe anaemia, porphyria)
  • Current (or history of) stomach or gastrointestinal tract disease
  • History of autonomic failure (e.g., vasovagal reflex syncope)
  • Experience of irregular sleep-wake rhythm
  • Current (or history of) obstructive respiratory disease
  • Current (or history of) clinically significant renal or hepatic disease
  • (Recent treatment of) glaucoma
  • Current (or history of) drug addiction (e.g. opiate, (meth)amphetamine, lysergic acid diethylamide, cocaine, solvents or barbiturate) or alcohol dependence
  • One first degree or two or more second degree family members with a recent treatment of sudden death or ventricular arrhythmia
  • Problems swallowing or problems with the oesophagus
  • Frequent experience of headrush (vertigo)
  • Current experience of an acute serious infection
  • First degree family member with schizophrenia or bipolar disorder
  • Abnormal hearing or (uncorrected) vision
  • Use of psychotropic medication or recreational drugs weekly or more over a period of more than three months in the last 6 months
  • Cannabis usage for the last 6 months
  • Strong smoking behaviour starting at more than 1 package of cigarettes per week
  • Hypersensitivity for e.g. beta blockers or methylphenidate
  • Uncontrolled hypertension, defined as diastolic blood pressure at rest \>95 mmHg or systolic blood pressure at rest \>180 mmHg
  • Irregular sleep/wake rhythm (e.g. regular nightshifts or cross timeline travel)
  • Possible pregnancy or breastfeeding/ inadequate anticonception (for women)
  • Lactose intolerance (because the placebo pill will be a lactose product)
  • Language related disabilities (e.g. dyslexia, stuttering)
  • Daily intense physical training

Key Trial Info

Start Date :

November 26 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 2 2021

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT05272397

Start Date

November 26 2019

End Date

December 2 2021

Last Update

April 1 2022

Active Locations (1)

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1

Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, Netherlands, 6525EN