Cognitive Biases in Decision Making in a Pharmacological Model of Psychosis : a Study in Healthy Humans Recieving Low Dose Anesthetic, Ketamine Versus Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Evidence for biaises in decision making in an uncertain environment.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed (as assessed by the Edinburgh scale)
- •Aged 18 to 39
- •Having given an informed consent
- •Health insurance
排除标准
- •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.
研究组 & 干预措施
Ketamine then placebo
Infusion of low dose Ketamine then infusion of a saline solution
干预措施: Ketamine (Drug)
Ketamine then placebo
Infusion of low dose Ketamine then infusion of a saline solution
干预措施: Placebo (Drug)
Placebo then ketamin
Infusion of a saline solution then infusion of low dose Ketamine
干预措施: Ketamine (Drug)
Placebo then ketamin
Infusion of a saline solution then infusion of low dose Ketamine
干预措施: Placebo (Drug)
结局指标
主要结局
Evidence for biaises in decision making in an uncertain environment.
时间窗: 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)
次要结局
- Clinician administred dissociatives states scales (CADSS)(30 and 90 minutes after infusion onset)
- Heart rate(Every 15 minutes during infusion)
- Brief Psychiatric Rating Scale (BPRS)(30 and 90 minutes after infusion onset)
- Blood pressure(Every 15 minutes during infusion)
- Electroencephalographic data(During infusion of Ketamine / Placebo (expected 2 hours))
- Pulse oxymetry(Every 15 minutes during infusion)