Brief description of trial (Data source: BASEC)
Das Ziel der Studie ist es, nicht-invasive Messungen von Verhalten, funktioneller Magnetresonanztomografie (fMRI) und Elektroenzephalografie (EEG) zu erhalten, welche mittels mathematischer Analyse erlauben, den Einfluss von Serotonin auf zielgerichtete Entscheidungsfindung festzustellen. Zusätzlich untersuchen wir, wie diese Prozesse durch individuelle Unterschiede in der Persönlichkeit und in serotonin-relevanten genetischen Polymorphismen beeinflusst werden.
In diesem Projekt wollen wir neurobiologische Mechanismen der Impulsivität in der Entscheidungsfindung bei gesunden Probanden mittels einer etablierten neuropharmakologischen Massnahme untersuchen. Genauer gesagt wollen wir den Beitrag des serotonergen Systems auf zielgerichtete Entscheidungsfindung in Verhaltensexperimenten untersuchen, die ein Gleichgewicht zwischen riskantem und belohnungssuchendem Verhalten sowie zwischen Unsicherheitstoleranz und inhibitorischer Kontrolle erfordern.
Health conditions investigated(Data source: BASEC)
Wir unsersuchen gesunde Probanden.
Health conditions
(Data source: WHO)
Healthy volunteers studied.
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Nach Abgabe einer einmaligen Dosis einer pharmakologischen Substanz (Escitalopram/Placebo, zwei Visiten bei der selben Person) führen die Probanden Verhaltensaufgaben entweder im fMRI (funktionelle Magnetresonanztomografie) oder im EEG (Elektroenzephalografie) durch.
Zusätzlich füllen die Probanden mehrere Persönlichkeitsfragebögen aus.
Interventions
(Data source: WHO)
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.
Criteria for participation in trial
(Data source: BASEC)
- Gesunde männliche Freiwillige im Alter von 18 bis 40 Jahre
- Rechtshänder
- europäische Abstammung
Exclusion criteria
(Data source: BASEC)
- keine neurologische oder psychiatrische Erkrankung oder andere schwere Erkrankung
- weiter MRI- und EEG-spezifische Ausschluss-Kriterien gemäss Studienprotokoll
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Male
Maximum age: 40 Years
Minimum age: 18 Years
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)
-
Further information on trial
Date trial registered
Jun 11, 2015
Incorporation of the first participant
Jul 21, 2015
Recruitment status
Complete
Academic title
(Data source: WHO)
Neurobiological basis of impulsivity in motivated decision-making - NBIMD
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: placebo; Assignment: crossover; Study design purpose: basic science
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
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.
Secundary end point
(Data source: WHO)
In addition, to examine how this dependence is influenced by individual differences in personality and serotonin-relevant genetic polymorphisms.
Contact information
(Data source: WHO)
Translational Neuromodeling Unit (TNU), University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
No
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Cole David
044 634 91 13
cole@biomed.ee.ethz.ch
Contact for general information
(Data source: WHO)
David
Cole
Wilfriedstrasse 6
Translational Neuromodeling Unit (TNU), Institut for Biomedical Engineering, University Zurich & Swiss Federal Institute of Technology (ETH) Zurich
+41 (0) 44 634 91 13
cole@biomed.ee.ethz.ch
Contact for scientific information
(Data source: WHO)
David
Cole
Wilfriedstrasse 6
Translational Neuromodeling Unit (TNU), Institute for Biomedical Engineering, University of Zurich & Swiss Federal Institute of Technology (ETH) Zurich
+41 (0) 44 634 91 13
cole@biomed.ee.ethz.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Further trial identification numbers
Secondary ID (Data source: WHO)
KEK-ZH-Nr. 2014-0514
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