University of Bonn
Bonn, North Rhine-Westphalia, 53111, Germany
NCT Number: NCT02701933
In this study, the investigators examine the effects of low-dose ketamine on different oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared to placebo, will lead to changes in task performance and brain activity similar to those observed in patients with schizophrenia.
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Notify Me18 year–45 year
Male
Interventional
Not applicable
Bonn, North Rhine-Westphalia, 53111, Germany
The uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has been proposed as a model system of the symptoms of schizophrenia. To complement this model system and to allow neurobiological as well as translational studies, biomarkers are often applied to people under the influence of ketamine. Here, we apply oculomotor, perceptual and cognitive biomarkers to healthy human volunteers whilst they undergo BOLD fMRI at 3 Tesla field strength. We use a counter-balanced, placebo-controlled, double-blind, within-subjects design. A sample of 25 healthy participants is required. Participants will receive intravenous (IV) racemic ketamine (with a 100ng/ml target plasma concentration) on one of two assessment days and they will receive placebo (intravenous saline) on the other assessment day. BOLD fMRI will be carried out on a Siemens Trio scanner at the Life&Brain Centre, Bonn. In addition to brain functional and cognitive, perceptual and oculomotor responses, we will also measure self-ratings of psychosis-like experiences. These will be obtained using the Psychotomimetic States Inventory (PSI; Mason et al 2008).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion
Other names: Ketamin Ratiopharm
Saline, intravenous infusion
Other names: Kochsalzloesung
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
The test requires the crossing out of the letter d combined with two dashes amidst letters d and p combined with one, two, three or four dashes and is a well-established measure of sustained attention
Time frame: after 5 days of washout period
Time frame: after 5 days of washout period
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
Time frame: within 1 hour of start of IV infusion
University of Bonn
Other
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