NCT02235012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

September 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

7.6 years

First QC Date

August 12, 2014

Last Update Submit

July 9, 2024

Conditions

Healthy Subjects

Keywords

SchizophreniaKetamineCognitive biasesUncertainty

Outcome Measures

Primary Outcomes (1)

  • 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)

    During infusion of Ketamine / Placebo (expected 2 hours)

Secondary Outcomes (6)

  • Electroencephalographic data

    During infusion of Ketamine / Placebo (expected 2 hours)

  • Brief Psychiatric Rating Scale (BPRS)

    30 and 90 minutes after infusion onset

  • Heart rate

    Every 15 minutes during infusion

  • Pulse oxymetry

    Every 15 minutes during infusion

  • Blood pressure

    Every 15 minutes during infusion

  • +1 more secondary outcomes

Study Arms (2)

Ketamine then placebo

EXPERIMENTAL

Infusion of low dose Ketamine then infusion of a saline solution

Drug: KetamineDrug: Placebo

Placebo then ketamin

EXPERIMENTAL

Infusion of a saline solution then infusion of low dose Ketamine

Drug: KetamineDrug: Placebo

Interventions

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

Ketamine then placeboPlacebo then ketamin
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

Ketamine then placeboPlacebo then ketamin

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75014, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Raphaël GAILLARD

    Centre Hospitalier St Anne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2014

First Posted

September 9, 2014

Study Start

September 8, 2014

Primary Completion

April 28, 2022

Study Completion

April 29, 2022

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

FR(1)