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Neurobiological basis of impulsivity in motivated decision-making

Organizational Data

DRKS-ID:
DRKS00008722
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2015-06-11
Last update in DRKS:
2016-06-21
Registration type:
Prospective

Acronym/abbreviation of the study

NBIMD

URL of the study

No Entry

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.

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.

Health condition or problem studied

Free text:
Healthy volunteers studied.
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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.
Arm 2:
Each subject serves as their own control through a counterbalanced, placebo-controlled (ingredient lactose) design.

Endpoints

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

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Placebo
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
  • Investigator/therapist
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Switzerland
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Translational Neuromodeling Unit, Institut für Biomedizinische Technik, Universität Zürich & ETH Zürich Zurich

Recruitment period and number of participants

Planned study start date:
2015-07-05
Actual study start date:
2015-07-21
Planned study completion date:
No Entry
Actual Study Completion Date:
2016-04-29
Target Sample Size:
100
Final Sample Size:
100

Inclusion Criteria

Sex:
Male
Minimum Age:
18 Years
Maximum Age:
40 Years
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

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)

Addresses

Primary Sponsor

Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Prof. Dr. med. Klaas Enno Stephan
Wilfriedstrasse 6
8032 Zurich
Switzerland
Telephone:
No Entry
Fax:
+41 (0) 44 634 91 25
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Dr. David Cole
Wilfriedstrasse 6
8032 Zurich
Switzerland
Telephone:
+41 (0) 44 634 91 13
Fax:
+41 (0) 44 634 91 31
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Translational Neuromodeling Unit (TNU), Institut for Biomedical Engineering, University Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Dr. David Cole
Wilfriedstrasse 6
8032 Zurich
Switzerland
Telephone:
+41 (0) 44 634 91 13
Fax:
+41 (0) 44 634 91 31
Contact per E-Mail
URL:
No Entry

Principal Investigator

Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Dr. David Cole
Wilfriedstrasse 6
8032 Zurich
Switzerland
Telephone:
+41 (0) 44 634 91 13
Fax:
+41 (0) 44 634 91 31
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Translational Neuromodeling Unit (TNU), University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Institute for Biomedical Engineering, Wilfriedstrasse 6,
8032 Zurich
Switzerland
Telephone:
No Entry
Fax:
+41 (0) 44 634 91 31
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Kantonale Ethikkommission Zürich [Cantonal Ethics Committee Zurich, Switzerland ]
Stampfenbachstrasse 121
CH-8090 Zürich
Switzerland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.kek.zh.ch/internet/gesundheitsdirektion/kek/de/home.html

Vote of leading Ethics Committee

Date of ethics committee application:
2014-09-17
Ethics committee number:
KEK-ZH-Nr. 2014-0514
Vote of the Ethics Committee:
Approved
Date of the vote:
2015-05-19

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry