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临床试验/NCT07074652
NCT07074652已完成不适用

The Effect of SSRIs on Threat of Shock Potentiated Neural Circuitry

UCLH/UCL Joint Research Office1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2017年12月1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
发起方
入组人数
145
试验地点
1
主要终点
'Aversive amplification circuit' connectivity

研究概览

简要总结

This study aims to increase the knowledge about psychological processes which may contribute to mental health problems such as depression and anxiety. This study aims to investigate if administering Escitalopram, an antidepressant which increases serotonin levels in parts of the brain, affects how the brain processes emotional information. It is hoped that measuring these changes will increase the understanding of processes involved in mental health problems.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Healthy Control - Escitalopram

Active Comparator

Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan.

干预措施: Escitalopram (Drug)

Healthy Control - Placebo

Placebo Comparator

Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan.

干预措施: Placebo (Drug)

Anxious Individuals - Escitalopram

Experimental

Participants took 10mg escitalopram for 2-3 weeks, once daily. Escitalopram was administered in the form of a tablet, manufactured and donated for research by Lundbeck (tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate; tablet coating: hypromellose 6cP, titanium dioxide (E171), macrogol 6000). Exact length of administration was dependent on participants' availability to attend their second scan.

干预措施: Escitalopram (Drug)

Anxious Individuals - Placebo

Placebo Comparator

Participants took a placebo tablet for 2-3 weeks, once daily. Placebo was administered in the form of a tablet, manufactured and donated for research by Lundbeck and matching the escitalopram tablet given to the other study groups in colour and size. Exact length of administration was dependent on participants' availability to attend their second scan.

干预措施: Placebo (Drug)

结局指标

主要结局

'Aversive amplification circuit' connectivity

时间窗: Baseline and 2-3 weeks after baseline

The engagement of the neural circuit of the amygdala, cingulate cortex and prefrontal cortex will be measured via an fMRI analysis technique called a psychophysiological interactions (PPI) analysis. PPI analysis concerns behaviour-specific increases in the relationship across regional brain activity - this means that it can allow one to assess whether two regions (a priori selected ROIs) show increased connectivity during a specific context or behaviour, suggesting a behaviour-specific increase in transfer of information. The output of this analysis will take form of a continuous beta weight - an index of connectivity across two brain regions (amygdala and medial prefrontal cortex), which represents the primary outcome of the study.

次要结局

  • Cognitive task performance: Loss/risk aversion task(Baseline and 2-3 weeks after baseline)
  • Cognitive task performance: Go/no-go task(Baseline and 2-3 weeks after baseline)
  • Cognitive task performance: Facial emotional processing task(Baseline and 2-3 weeks after baseline)
  • Cognitive task performance: Visual affective bias task(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measure: Generalised Anxiety Disorder Scale (GAD-7)(Baseline and 2-3 weeks after baseline)
  • Cognitive task performance: Emotional face recognition task(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Beck's Depression Inventory (BDI)(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Catastrophizing questionnaire(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Daily Stress Inventory (DSI)(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Behavioural Inhibition/Behavioural Activation Scales (BIS/BAS)(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Eysenck Impulsiveness Scale(Baseline and 2-3 weeks after baseline)
  • Regional activations during neuroimaging task: Facial emotional processing task(Baseline and 2-3 weeks after baseline)
  • Regional activations during neuroimaging task: Emotional face recognition task(Baseline and 2-3 weeks after baseline)
  • Regional activations during neuroimaging task: Visual affective bias task(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measure: State Trait Anxiety Inventory (STAI)(Baseline and 2-3 weeks after baseline)
  • Clinical symptom measures: Patient Health Questionnaire (PHQ-9)(Baseline and 2-3 weeks after baseline)

研究者

发起方
UCLH/UCL Joint Research Office
申办方类型
Other
责任方
Sponsor

研究点 (1)

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