Healthy Subjects Clinical Trial
Official title:
Cognitive Biases in Decision Making in a Pharmacological Model of Psychosis : a Study in Healthy Humans Recieving Low Dose Anesthetic, Ketamine Versus Placebo
Characterise cognitive biases resulting from low dose ketamine infusion, used as a
pharmacological model of psychosis.
Our assumption is that low dose ketamine results in reasoning biases by impairing the way
uncertainty is monitored and taken into account for decision making.
Ketamine is a non-competitive glutamate NMDA antagonist. The infusion of subanesthetic doses
of ketamine results in sub-clinical schizophrenia-like positive symptoms in healthy controls.
The safety of ketamine use is attested by its daily use in child anesthesia and by a number
of studies showing there is no medical, neural or cognitive complication after a single
infusion.
Low dose ketamine is therefore a valid and safe human model to study psychosis. The objective
of the study is to characterise cognitive biases resulting from low dose ketamine infusion,
used as a pharmacological model of psychosis.
We designed four distinct paradigms designed to better characterize these biases.
P1 is a neuroeconomic task where subjects have to make binary choices to maximize gains, in a
situation where either direct feedback information or additional counterfactual information
is provided.
P2 is a neuroeconomic task where a direct manipulation of uncertainty is performed, and its
impact on decision is measured.
P3 is a perceptual decision making task, where subjects have to classify a gabor orientation
into the diagonal or cardinal category based on a rapidly presented series of individual
gabors. The contribution of each piece of evidence to the final decision is measured and
correlated to fluctuations in eeg data.
P4 is a perceptual decision making task, where subjects have to determine the global
orientation of a series of sequentially presented gabor stimulus. There are interim responses
and final responses, the influence of the former on the latter (confirmation bias) is
studied.
Our assumption is that low dose ketamine results in reasoning biases by impairing the way
uncertainty is monitored and taken into account for decision making.
The study design is as follows : randomized, double blind, controlled, against placebo,
cross-over.
Healthy subjects will therefore be randomized to receive on the first visit either a ketamine
infusion or a placebo infusion. The alternative condition will be applied on the second
visit.
Ketamine will be prepared using KETAMINE PANPHARMA 250 mg/5mL, and infusion will be. This
procedure should produce ketamine plasmatic levels of 140ng/ml. Two blood samples will be
taken 30 and 90 minutes after infusion start to record actual ketamine plasmatic levels.
Placebo infusion will follow the same pattern of infusion, prepared using CHLORURE DE SODIUM
0,9% MACOPHARMA.
We will record both behavioral, electrophysiologic and psychometric data. Detailed
assumptions are as folllows :
Behavioral data :
P1 and 2 : Significant impairment with ketamine in the ability to take into account
uncertainty to guide decisions.
P3 : Significant decrease with ketamine in the ability to classify correctly the mean spatial
orientation of stimuli according to the cardinal or diagonal direction.
P4 : Significant increase with ketamine in the confirmation bias following the interim
choice.
Electroencephalographic data :
Correlation between the impairment in the ability to take into account uncertainty and the
alteration of the Error Related Negativity and late inhibitory eeg signals, and decreased
long distance synchrony as indicated by spectral analysis (P1 and 2).
The covariation of brain activity with the weight each stimuli sample will have in the final
decision, will be increased as a result of ketamine infusion (P3).
Psychometric data :
Increase in the Brief Psychiatric Rating Scale (BPRS) as a result of ketamine infusion. The
BPRS scale records the psychotic symtoms and is translated and validated in a french
population sample.
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