The aim of this project is to assess the acute effects of the N-methyl-D-aspartate receptor antagonist S(+)-Ketamine compared to placebo on body and self-perception, using cognitive experimental tasks and EEG in healthy volunteers.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the neural and behavioral effects of
S-ketamine relative to placebo. Specifically, we examine the neural effects of
S-ketamine on event-related potentials (ERPS) in a sensory suppression task and
in a trait-adjective task. Additionally, we examine the effects of S-ketamine
on perception of peripersonal space, feelings of feelings of embodiment and
perception of heart rate, through behavioral-experimental tasks and
measurements.
Secondary outcome
The secondary outcome measures of this study are the effects of S-ketamine on
subjective perception, measured by questionnaires and an interview; the
relationship between the subjective measures and neural and behavioral effects;
and the relationship between personality factors and subjective effects.
Background summary
The selective NMDA-antagonist ketamine is widely used as a general anesthetic
and is increasingly being prescribed as an anti-depressant for patients
suffering from major depressive disorder (MDD). Whereas ketamine*s psychotropic
effects, including feelings of dissociation, disembodiment and derealization,
have long been considered side-effects, recent evidence indicates that
ketamine-induced changes in body and self-perception may contribute to its
therapeutic efficacy. Addressing these changes and their underlying
neurocognitive mechanisms, bears relevance for the understanding of other
disorders that are also characterized by aberrant processing of interoceptive
and exteroceptive bodily signals, such as anxiety, post-traumatic stress
disorder and anorexia nervosa. To this end, the current study integrates
previous neurochemical models of ketamine with recent computational and
Bayesian models of body- and self-perception. By using state-of-the-art
experimental cognitive tasks combined with electroencephalogaphy (EEG)
measures, central predictions regarding the neurocognitive mechanisms
underlying ketamine-induced changes in body perception will be assessed.
Thereby this study will extend our knowledge about the primary mechanisms of
action of ketamine, the neurocognitive basis of bodily self-consciousness and
its relation to clinical disorders.
Study objective
The aim of this project is to assess the acute effects of the
N-methyl-D-aspartate receptor antagonist S(+)-Ketamine compared to placebo on
body and self-perception, using cognitive experimental tasks and EEG in healthy
volunteers.
Study design
This study uses a within-subjects double-blind cross-over experimental design.
Participants will participate in two experimental sessions, in which they
receive either S(+)-ketamine or saline.
Intervention
In the S(+)-ketamine session, subjects will receive an intravenous (IV)
administration of a continuous infusion of 20 mg /h (per 70 kg) for 1 hour,
followed by an infusion of 30 mg /h (per 70 kg) for 1.5 hours. In the placebo
session, participants will receive an IV administration of 50ml of saline
solution.
Study burden and risks
In total the study consists of a 20-minute screening, and two times a 5-hour
experimental session in the lab, followed by an exit interview. During the
lab-visits, subjects will conduct approximately 2 hours of questionnaires and
different experimental tasks, and EEG measures will be recorded. The doses of
S(+)-ketamine used in this study are moderate and comparable to those used in
previous studies at the LUMC. The outcomes of the study will provide new
insight in the neurocognitive mechanisms underlying the acute effects of
ketamine on body and self-perception. Participants will receive a reimbursement
of ยค220 for completion of the study.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
1. Healthy male or female volunteers; 2. Age: 18 - 40 years; 3. Body mass index
< 30 kg/m2 4. Able to give informed consent. 5. Be able to speak and understand
English.
Exclusion criteria
1. Known or suspected neuromuscular or a (family) history of any neuromuscular
disease 2. A history of allergic reaction to food or medication including study
medication 3. Any current or previous medical (including high blood pressure),
neurological or psychiatric illness (including a history of anxiety) 4. Alcohol
abuse (> 21 units/week) 5. Illicit drug use in the past 30 days before
inclusion 6. Pregnancy or lactation 7. Participation in any medical or drug
trial in the month prior to the current study
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84218.058.23 |