Trial document




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  DRKS00008722

Trial Description

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Title

Neurobiological basis of impulsivity in motivated decision-making

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Trial Acronym

NBIMD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In this project, we wish to probe brain mechanisms of impulsive decision-making in healthy volunteers, using a combination of behavioural and genetic testing, brain imaging and drug administration (escitalopram vs. placebo in the same individuals). Specifically, we aim to examine the contribution of the brain chemical serotonin to impulsivity in goal-directed decision-making. We will study healthy male adult volunteers aged 18-40, right-handed, of European ancestry and with no history of neurological, psychiatric or major physical disorder. As this is a basic science study, there are no primary or secondary outcomes/end points per se.

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Brief Summary in Scientific Language

In this project, we wish to probe neurobiological mechanisms of impulsivity in decision-making in healthy volunteers, using established neuropharmacological tools. Specifically, we aim to delineate the contribution of the serotonergic system to goal-directed, probabilistic decision-making in behavioural paradigms that require a balance between risk-taking/reward-seeking behaviour and uncertainty tolerance/inhibitory control. Our objectives are to obtain non-invasive measures of behaviour, functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) which allow
us to determine, using mathematical analysis, the dependence of goal-directed decision-making on levels of serotonin. In addition, we will examine how this dependence is influenced by individual differences in personality and serotonin-relevant genetic polymorphisms.

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Organizational Data

  •   DRKS00008722
  •   2015/06/11
  •   [---]*
  •   yes
  •   Approved
  •   KEK-ZH-Nr. 2014-0514, Cantonal Ethics Committee Zurich, Switzerland
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Healthy volunteers studied.
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Interventions/Observational Groups

  •   Escitalopram, 15mg single dose; Sub-Arm 1 is a functional magnetic resonance imaging (fMRI) study in 50 healthy young adult male volunteers; Sub-Arm 2 is an electroencephalography (EEG) study in 50 healthy young adult male volunteers.

    Each subject receives in addition a structrual MRI scan, ECG, personality questionnaires, blood plasma metabolite and genetic testing.
  •   Each subject serves as their own control through a counterbalanced, placebo-controlled (ingredient lactose) design.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

To obtain non-invasive measures of behaviour, fMRI and EEG which allow us to determine, using mathematical analysis, the dependence of goal-directed decision-making on levels of serotonin.

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Secondary Outcome

In addition, to examine how this dependence is influenced by individual differences in personality and serotonin-relevant genetic polymorphisms.

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Countries of Recruitment

  •   Switzerland
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/07/21
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

• Age from 18 to 40 years
• Male sex
• European ancestry
• Right-handedness
• Written informed consent
• Consent to adhere to the study protocol
• Ability to adhere to the study protocol

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Exclusion Criteria

• Serious past or present brain disease, brain injury or brain surgery
• Any neurological or psychiatric disorders (past or present)
• Nicotine/tobacco use of more than 10 cigarettes per week, or equivalent
• Current use of recreational drugs
• History of alcohol and/or drug abuse
• Any current severe medical condition
• Currently taking medication of any kind
• Allergy to lactose (placebo) or to escitalopram
• Tachycardia >100 bpm, cardiac arrhythmia and/or QTc time >430 ms
• History of severe kidney or liver disorder
• Pacemaker, neurostimulator or any other head or heart implants
• Any breathing difficulties
• Claustrophobia
• Dependence on a hearing aid
• Bald head or dreadlocks (EEG only)
• Inability to sit still (EEG) or lie still (MRI) for the duration of the experiment (sneezing, coughing,
itching, trembling, twitching, pain, etc.)
• Subjects with MRI-incompatible metal parts in the body
• Possibility of the presence of any metal fragments in the body (e.g., metal splinters, ballistic
wounds, shrapnel or surgical clips)

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Addresses

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    • Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
    • Mr.  Prof. Dr. med.  Klaas Enno  Stephan 
    • Wilfriedstrasse 6
    • 8032  Zurich
    • Switzerland
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    • Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
    • Mr.  Dr.  David  Cole 
    • Wilfriedstrasse 6
    • 8032  Zurich
    • Switzerland
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    • Translational Neuromodeling Unit (TNU), Institut for Biomedical Engineering, University Zurich & Swiss Federal Institute of Technology (ETH) Zurich
    • Mr.  Dr.  David  Cole 
    • Wilfriedstrasse 6
    • 8032  Zurich
    • Switzerland
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Sources of Monetary or Material Support

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    • Translational Neuromodeling Unit (TNU), University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
    • Mr.  Prof. Dr. med.  Klaas Enno  Stephan 
    • Institute for Biomedical Engineering, Wilfriedstrasse 6,
    • 8032  Zurich
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/29
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Trial Publications, Results and other Documents

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