Healthy Participants Clinical Trial
Official title:
Influence of Partial Blockade of Dopaminergic Neurotransmission Using Amisulpride on Stress Responsivity, Motivated Behavior and Emotional Reactivity in Humans.
The study aims to identify whether partial blockade of human dopamine signaling with
antipsychotic drugs affects human stress responses, motivation and emotion. 84 healthy adult
participants are planned to complete the study protocol.
Therefore three experiments are planned:
Experiment 1: Influence of amisulpride on human stress responses. Experiment 2: Influence of
amisulpride on motivated effort. Experiment 3: Influence of amisulpride on emotion.
The study is a double blind, placebo controlled, randomized trial with two groups. One group
will be receiving placebo (PG) and the other group will receive 300 mg amisulpride (VG). All
participants are planned to complete all three experiments sequentially after drug/placebo
intake.
In experiment 1 we want to test whether a medium single dosage of amisulpride (VG) changes
human stress responses compared to the PG. Therefore test subjects take the medication /
placebo and wait for peak plasma levels. Afterwards they undergo a standardized stress test
(MAST procedure,e.g. Shilton et al., 2017) where they submerge their non-dominant hand in
cold water and have to do mental arithmetic tasks. We collect ECG, cortisol and skin
conductance data as well as subjective measures of the stress response.
In experiment 2 that is done after completion of experiment 1 the aim is testing whether the
VG compared to the PG has an altered motivated effort. Therefore so called effort based
paradigms (Reddy et al., 2015) are used. In these paradigms participants are given the option
between an easy and effortless way of solving a trial that is reinforced with a small
monetary reward or a harder and effortful way of trial solving that is rewarded higher. We
measure how often the VG versus the PG will take the easy, low reward option over the hard,
high reward option.
In experiment 3 and after the completion of experiment to the aim is it to test whether the
mean intensity of visually evoked emotions in the VG is changed compared to the PG. Therefore
we use a stimulus set (15 positive images, 15 negative images, 15 neutral images) out of the
International Affective Picture System images to evoke emotions and plan to analyze data like
in positivity offset research (detailed description in: Strauss et al, 2017).
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