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临床试验/NCT03961464
NCT03961464已完成不适用

The Effect of NMDA Receptor Partial Agonist D-cycloserine on Emotional Processing, Stress and Memory in Healthy Volunteers

University of Oxford1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Performance in a facial expression recognition task

研究概览

简要总结

To investigate the effects of N-methyl-D-aspartate (NMDA) partial agonist DCS on emotional processing, memory and stress tasks

详细描述

The aim of the present study is to assess the effect of DCS on emotional processing relevant to antidepressant drug activity. For this, 40 healthy volunteers will be recruited to the study and randomized to receive a single session of 250mg DCS or placebo. 3 hours and 24 hours after active drug/placebo administration, the effects of emotional processing via the use of cognitive tasks will be assessed. Also, given the important role of DCS in memory and stress, we also include tasks to explore changes in autobiographical memory and in psychological and physiological measures of stress and arousal.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Willing and able to give informed consent for participation in the study
  • Body mass index (BMI) within the range of 19-30kg/m2
  • Sufficiently fluent English to understand and complete the task

排除标准

  • Currently take any psychoactive medication.
  • Have taken any CNS-active medication during the last 6 weeks.
  • Currently take any medication with cycloserine, ethionamide or isoniazid
  • Have suffered from any past or current psychiatric disorder (e.g. depression, anxiety)
  • Have lifetime history of epilepsy or other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Have history of heart disease, significant hypertension
  • Have history of Megaloblastic Anaemia, Sideroblastic Anaemia
  • Have history of kidney disease with reduction in kidney function
  • Have severe renal impairment
  • Have suffered from lactose intolerance
  • Are currently pregnant, breastfeeding or trying to get pregnant
  • Have a current or past history of drug or alcohol dependency
  • Have participated in a psychological or medical study involving the use of medication within the last 3 months
  • Have previously participated in a study using the same, or similar, emotional processing tasks
  • Smoke more than 5 cigarettes per day
  • Have dyslexia (given the nature of the computer tasks)

研究组 & 干预措施

d-cycloserine

Experimental

oral, capsule, 250 mg

干预措施: d-cycloserine (Drug)

Placebo

Experimental

oral, capsule, lactose

干预措施: Placebo (Drug)

结局指标

主要结局

Performance in a facial expression recognition task

时间窗: 3 hours after drug/placebo administration

Participants are presented with individual pictures of facial expressions of emotions. Each presented face displays one of six basic emotions (anger, disgust, fear, happiness, sadness, or surprise). Each emotional expression is presented at different levels of intensity which have been created by combining shape and texture features of the two extremes "neutral" (0%) and "full prototypical emotion" (100%) to varying degrees. Examples of neutral facial expressions are presented as well. Participants are instructed to correctly classify each facial expression as angry, disgusted, fearful, happy, sad, surprised or neutral both as quickly and as accurately as possible. Responses are made by pushing one out of seven labelled keys on a response box. Hit rates, false alarm rates, and reaction times for correct classifications are measured separately for each emotion.

Performance in an emotional recall task

时间窗: 3 hours after drug/placebo administration

Following a delay period after the emotional categorisation task (about 15 min), emotional recall memory is assessed. Participants are asked to recall and write down as many words as possible from the emotional categorization task. Numbers of correctly and incorrectly recalled positive and negative words are measured.

Performance in an autobiographical memory task

时间窗: 3 hours after drug/placebo administration

The autobiographical memory cues are presented visually on computer screen in a fixed order, with positive, negative, and neutral words alternating, each word will be presented only once. Participants are instructed that, for each cue word, they should respond with a memory of an autobiographical event which had lasted less than 1 day and which had occurred at a specific time and place. They are told that the event could have occurred recently or a long time ago and could have been important or trivial but that no responses should be repeated for a subsequent word. Correct and incorrect examples are given. Responses are tape-recorded for subsequent coding.

次要结局

  • Performance in an emotional categorisation task(3 hours after drug/placebo administration)
  • Performance in a cognitive stress task(3 hours after drug/placebo administration)
  • Performance in an emotional recognition task(Emotional recognition memory is assessed by presenting participants with the original personality descriptors plus an equal number of matched distractor words (50% positive, 50% negative). Participants are asked to ind)
  • Performance in a facial expression recognition task(24 hours after drug/placebo administration)
  • Performance in an emotional recall task(24 hours after drug/placebo administration)
  • Performance in an emotional faces dot probe task(3 hours after drug/placebo administration)
  • Performance in an autobiographical memory task(24 hours after drug/placebo administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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The Effect of D-cycloserine on Emotional Processing | 临床试验