General and Anxiety-Linked Influence of Acute Serotonin Reuptake Inhibition on Neural Responses Associated With Attended Visceral Sensation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- relative neural interoceptive response - heart
研究概览
简要总结
The goal of this crossover study was to learn about the potential regulatory role of serotonin in interoceptive processing and its relationship to levels of state anxiety. This experiment directly compared the impact of a selective serotonin reuptake inhibitor (SSRI) (20mg CITALOPRAM) to that of a PLACEBO on the neural processing of ordinary interoceptive sensations and the relationship of these influences to anxious states.
Healthy young volunteers completed the visceral interoceptive attention task with each treatment condition (citalopram and placebo). The task involves focusing attention on heart, stomach, or visual sensation control while scanned with functional magnetic resonance imaging (fMRI). The difference in haemodynamic response between interoceptive sensation(s) and visual sensation (i.e. the relative interoceptive response) is compared between treatment conditions. State anxiety is measured at each test period. It is used to test for a moderating effect of state anxiety on the influence of serotonin in interoceptive processing and used post-hoc to explore associations between changes in state anxiety and changes of interoceptive relative interoceptive response due to the SSRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteer
- •Exclusion criteria included:
- •the presence of significant ongoing medical condition;
- •pregnancy or breastfeeding;
- •currently taking any medication (excluding contraceptive pill);
- •first-degree family history of bipolar disorder;
- •an indication of current or historical mental health disorder,
- •MRI scanner contraindications (e.g. metallic implants)
- •data that is unanalyzable due to movement
- •excessive side effects of the drug (e.g. nausea)
排除标准
- 未提供
研究组 & 干预措施
citalopram first, placebo second
Citalopram was taken first. Placebo was taken at least 7 days later.
干预措施: Citalopram 20mg (Drug)
citalopram first, placebo second
Citalopram was taken first. Placebo was taken at least 7 days later.
干预措施: Placebo (Drug)
placebo first, citalopram second
Placebo was taken first. Citalopram was taken at least 7 days later.
干预措施: Citalopram 20mg (Drug)
placebo first, citalopram second
Placebo was taken first. Citalopram was taken at least 7 days later.
干预措施: Placebo (Drug)
结局指标
主要结局
relative neural interoceptive response - heart
时间窗: 15 minutes
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the heart, minus the response during focus on a visual stimulus
relative neural interoceptive response - stomach
时间窗: 15 minutes
Neural response, inferred via functional magnetic resonance imaging from focusing attention on the stomach, minus the response during focus on a visual stimulus
State Anxiety
时间窗: 5 minutes
State Trait Anxiety Inventory
次要结局
- Metacognitive Interoceptive Insight(45 minutes)
- Physiological and Psychological state(Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.)
- Cerebral Blood Flow Change(2 minutes, at scan)
- Positive and Negative Affect Scale(Measured twice, for 2 minutes, before and after scanning. Average taken to estimate state inside scanner.)
- Heartrate(Before scans of each session, 2 minutes)
- Anatomical scan and fieldmaps(6 minutes, at scan)
研究者
Daniel Campbell-Meiklejohn
Senior Lecturer
University of Sussex