Effects of Caffeine on Anxiety, Emotional Processing, Approach-avoidance Behavior, and Interoception in Panic Disorder - a Double Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Self-reported anxiety
研究概览
简要总结
The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including participants with Panic disorder and healthy controls.
The study's primary aim is to investigate the effects of caffeine (vs placebo) on self-reported anxiety and its impact on emotional reactivity and goal-directed behavior in individuals with Panic disorder (vs healthy controls). Emotional reactivity will be measured with self-reported emotions and skin conductance responses. Caffeine-induced effects on goal-directed behavior will be assessed using an approach-avoidance conflict paradigm and an effort-allocation task. The occurrence of panic attacks and panic-related symptoms will also be measured. Furthermore, the link between a genotype of ADORA2A (rs5751876 T/T) previously associated with caffeine-induced anxiety, and the anxiogenic effects of caffeine will also be explored. In addition, caffeine-induced changes in attention to interoceptive stimuli (bodily sensation such as pulse and respiration) and anxiety elicited by attention to interoceptive stimuli will be explored. A secondary aim is to examine the potential caffeine-induced effects and the impact of genetic variation in healthy participants (caffeine vs placebo).
详细描述
Hypotheses
Self-reported anxiety during resting state
- Participants with Panic disorder will report higher resting-state levels of anxiety and negative emotions during the caffeine condition vs the placebo condition.
- Participants with Panic disorder will report higher resting-state levels of caffeine-induced (caffeine > placebo) anxiety and negative emotions compared to healthy subjects.
Panic attacks
- The occurrence of panic attacks and panic-related symptoms will be higher among participants with Panic disorder than in healthy controls in both conditions (caffeine and placebo).
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
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Panic disorder group: Primary diagnosis of panic disorder.
- •Healthy control group: No current or history of psychiatric disorders.
- •All participants (Panic disorder and healthy): Weekly caffeine consumption ≤ 300 mg.
排除标准
- •History of severe psychiatric disorder (e.g. schizophrenia). Somatic or neurological conditions (e.g. hypertension and heart condition). Ongoing treatment with psychotropic medication or treatment with psychotropic medication which has been discontinued within 2 months. Other ongoing treatments that may confound the results. Current drug or alcohol abuse/dependency. Habitual nicotine use. Uncorrected visual or hearing impairment. Pregnancy.
研究组 & 干预措施
Panic disorder
Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
干预措施: Caffeine (Dietary Supplement)
Panic disorder
Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
干预措施: Placebo (Drug)
Healthy controls
Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
干预措施: Caffeine (Dietary Supplement)
Healthy controls
Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).
干预措施: Placebo (Drug)
结局指标
主要结局
Self-reported anxiety
时间窗: Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))
Anxiety will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=no anxiety - 100=extreme anxiety).
次要结局
- Self-reported emotions(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Occurrence of panic attack(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Panic symptoms(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Attention to interoceptive stimuli(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Skin conductance responses (SCR)(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Approach-avoidance behavior(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Effort-allocation(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))
- Anxiety associated with attention to interoceptive stimuli(Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1)))