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Cognitive Biases Under Ketamine (KETABI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235012
Recruitment Status : Unknown
Verified October 2017 by Centre Hospitalier St Anne.
Recruitment status was:  Recruiting
First Posted : September 9, 2014
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Fondation pour la Recherche Médicale
Fondation Fyssen
Comité pour la Recherche Hospitalière Médicale
Association Schizo Oui
Information provided by (Responsible Party):
Centre Hospitalier St Anne

Brief 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.


Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Ketamine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 8, 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine then placebo
Infusion of low dose Ketamine then infusion of a saline solution
Drug: Ketamine

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

Drug: Placebo

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

Experimental: Placebo then ketamin
Infusion of a saline solution then infusion of low dose Ketamine
Drug: Ketamine

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

Drug: Placebo

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Electroencephalographic data [ Time Frame: During infusion of Ketamine / Placebo (expected 2 hours) ]

    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)


  2. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 30 and 90 minutes after infusion onset ]
  3. Heart rate [ Time Frame: Every 15 minutes during infusion ]
  4. Pulse oxymetry [ Time Frame: Every 15 minutes during infusion ]
  5. Blood pressure [ Time Frame: Every 15 minutes during infusion ]
  6. Clinician administred dissociatives states scales (CADSS) [ Time Frame: 30 and 90 minutes after infusion onset ]


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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right-handed (as assessed by the Edinburgh scale)
  • Aged 18 to 39
  • Having given an informed consent
  • Health insurance

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235012


Contacts
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Contact: Raphaël GODARD, MD, PhD 00 33 1 45 65 81 54 r.gaillard@ch-sainte-anne.fr
Contact: Marie GODARD 00 33 1 45 65 77 28 m.godard@ch-sainte-anne.fr

Locations
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France
Centre Hospitalier Sainte Anne Recruiting
Paris, France, 75014
Contact: Raphaël GAILLARD, MD, PhD    00 33 1 45 65 81 54    r.gaillard@ch-sainte-anne.fr   
Contact: Marie GODARD    00 33 1 45 65 77 28    m.godard@ch-sainte-anne.fr   
Sponsors and Collaborators
Centre Hospitalier St Anne
Fondation pour la Recherche Médicale
Fondation Fyssen
Comité pour la Recherche Hospitalière Médicale
Association Schizo Oui
Investigators
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Principal Investigator: Raphaël GAILLARD Centre Hospitalier St Anne

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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT02235012    
Other Study ID Numbers: D512
2013-002056-33 ( EudraCT Number )
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by Centre Hospitalier St Anne:
Schizophrenia
Ketamine
Cognitive biases
Uncertainty
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action