Healthy SubjectsKETABINCT02235012
Cognitive Biases Under Ketamine
A study testing Ketamine in people with Healthy Subjects, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2014to 29 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed (as assessed by the Edinburgh scale)
- Aged 18 to 39
- Having given an informed consent
- Health insurance
Who cannot join
- Pregnant or breastfeeding woman (a urine pregnancy test will be offered in doubt)
- Personal or first-degree family history of psychosis
- Personal history of mood disorder, anxiety disorder, obsessive-compulsive disorder, somatoform disorder, dependence on a psychoactive substance, behavior disorder incompatible with a 2 hours EEG recording.
- Psychotropic treatment, current or stopped for less than 1 month, including antidepressant, anxiolytic but excluding hypnotic treatments.
- Personal history of neurologic disorder in relation to the central nervous system : congenital malformation of the brain, brain tumor, multiple sclerosis, degenerative disease of the central nervous system, epilepsy, current or in remission for less than 3 years or still requiring a medical treatment, inflammatory disease of the central nervous system dating under a year or having resulted in sequelae.
- Known hypertension or blood pressure above 140/90 mmHg upon clinical examination, congenital heart disease, ischemic heart disease, cardiac insufficiency, supraventricular and ventricular heart rhythm disorder.
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- Person with restricted liberty, as a result of judicial or administrative measures
- Persons under involuntary commitment as a result of a psychiatric disorder.
- Person subject to a measure of legal protection or unable to consent.
- Known intolerance ketamine.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Subjects
- Being tested
- Ketamine, Placebo
- Keywords
- Schizophrenia, Ketamine, Cognitive biases, Uncertainty
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
KETAMINE PANPHARMA 250 mg/5mL, solution for infusion :
- Initial rapid infusion of 0,23 mg/kg
- Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min
- Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min
PlaceboDrug
CHLORURE DE SODIUM 0,9 % MACOPHARMA :
- Initial rapid infusion of 0,23 mg/kg
- Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min
- Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Ketamine then placebo | Experimental | Infusion of low dose Ketamine then infusion of a saline solution Receives: Drug: Ketamine; Drug: Placebo |
| Placebo then ketamin | Experimental | Infusion of a saline solution then infusion of low dose Ketamine Receives: Drug: Ketamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence for biaises in decision making in an uncertain environment.
Behavioural analyses of decision making during the neuroeconomic or perceptual decision makin tasks (Paradigms 1 to 4)
Measured: During infusion of Ketamine / Placebo (expected 2 hours)
Secondary outcomes (6)
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 (Paradigms 1 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 (Paradigm 3)
Measured: During infusion of Ketamine / Placebo (expected 2 hours)
Brief Psychiatric Rating Scale (BPRS)
Measured: 30 and 90 minutes after infusion onset
Heart rate
Measured: Every 15 minutes during infusion
Pulse oxymetry
Measured: Every 15 minutes during infusion
Blood pressure
Measured: Every 15 minutes during infusion
Clinician administred dissociatives states scales (CADSS)
Measured: 30 and 90 minutes after infusion onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start8 Sep 2014
- Primary completion28 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale, Fondation Fyssen, Comité pour la Recherche Hospitalière Médicale, Association Schizo Oui
- Responsible party
- Sponsor
- Investigators
- Raphaël GAILLARD, Principal investigator, Centre Hospitalier St Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235012
- Sponsor's protocol ID
- D512
- Other IDs
- 2013-002056-33
- Acronym
- KETABI
- Status last verified
- Jul 2024
- First submitted
- 12 Aug 2014
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02235012
- Acronym / sponsor ID
- KETABI / D512
- Conditions
- Healthy Subjects
- Keywords
- Schizophrenia, Ketamine, Cognitive biases, Uncertainty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Fondation pour la Recherche Médicale, Fondation Fyssen, Comité pour la Recherche Hospitalière Médicale, Association Schizo Oui
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine then placebo | Experimental | Drug: Ketamine, Drug: PlaceboInfusion of low dose Ketamine then infusion of a saline solution |
| Placebo then ketamin | Experimental | Drug: Ketamine, Drug: PlaceboInfusion of a saline solution then infusion of low dose Ketamine |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Right-handed (as assessed by the Edinburgh scale)
- Aged 18 to 39
- Having given an informed consent
- Health insurance
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding woman (a urine pregnancy test will be offered in doubt)
- Personal or first-degree family history of psychosis
- Personal history of mood disorder, anxiety disorder, obsessive-compulsive disorder, somatoform disorder, dependence on a psychoactive substance, behavior disorder incompatible with a 2 hours EEG recording.
- Psychotropic treatment, current or stopped for less than 1 month, including antidepressant, anxiolytic but excluding hypnotic treatments.
- Personal history of neurologic disorder in relation to the central nervous system : congenital malformation of the brain, brain tumor, multiple sclerosis, degenerative disease of the central nervous system, epilepsy, current or in remission for less than 3 years or still requiring a medical treatment, inflammatory disease of the central nervous system dating under a year or having resulted in sequelae.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineKETAMINE PANPHARMA 250 mg/5mL, solution for infusion : * Initial rapid infusion of 0,23 mg/kg * Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min * Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min | Drug | Ketamine then placebo, Placebo then ketamin |
| PlaceboCHLORURE DE SODIUM 0,9 % MACOPHARMA : * Initial rapid infusion of 0,23 mg/kg * Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min * Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min | Drug | Ketamine then placebo, Placebo then ketamin |
Primary outcome
Evidence for biaises in decision making in an uncertain environment.
Time frame: During infusion of Ketamine / Placebo (expected 2 hours)
Behavioural analyses of decision making during the neuroeconomic or perceptual decision makin tasks (Paradigms 1 to 4)
6 secondary outcomes
Electroencephalographic data
Time frame: During infusion of Ketamine / Placebo (expected 2 hours)
Brief Psychiatric Rating Scale (BPRS)
Time frame: 30 and 90 minutes after infusion onset
Heart rate
Time frame: Every 15 minutes during infusion
Pulse oxymetry
Time frame: Every 15 minutes during infusion
Blood pressure
Time frame: Every 15 minutes during infusion
Clinician administred dissociatives states scales (CADSS)
Time frame: 30 and 90 minutes after infusion onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaël GAILLARD principal investigator
Centre Hospitalier St Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Healthy Subjects, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence for biaises in decision making in an uncertain environment. (time frame: During infusion of Ketamine / Placebo (expected 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024; AzTrials last refreshed its copy on 27 Oct 2026.