Neurobiological basis of impulsivity in motivated decision-making

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00008722
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
• Public title: Neurobiological basis of impulsivity in motivated decision-making
• Scientific title: Neurobiological basis of impulsivity in motivated decision-making - NBIMD
• Date of first enrolment: 21/07/2015
• Target sample size: 100
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00008722
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: crossover; Study design purpose: basic science
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: David Cole
• Affiliation: Translational Neuromodeling Unit (TNU), Institut for Biomedical Engineering, University Zurich & Swiss Federal Institute of Technology (ETH) Zurich

• Name: David Cole
• Affiliation: Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich

Key inclusion & exclusion criteria

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)

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy volunteers studied.

Intervention(s)

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

Primary Outcome(s)

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(s)

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

Source(s) of Monetary Support

Translational Neuromodeling Unit (TNU), University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich

Ethics review

Status: Approved
Approval date: 19/05/2015
Contact:

Kantonale Ethikkommission Zürich [Cantonal Ethics Committee Zurich, Switzerland ]

Results

• Date Completed: 29/04/2016
• URL: http://drks.de/search/en/trial/DRKS00008722#studyResults