Adenosine Receptors from Genes to Behavior: Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance, Decision-Making and Interoception in Healthy Individuals and Panic Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Task-related BOLD fMRI signal
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 Healthy Controls (HC) and participants with Panic Disorder (PD).
The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study.
Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception.
Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner.
A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.
详细描述
Given the novelty of the intended study and the lack of previous neuroimaging and emotion-related behavioral studies on caffeine effects in HCs and PD, analyses will be exploratory without directed hypotheses.
It is intended to conduct between-group analyses (HCs vs PD) in the two conditions (caffeine versus placebo), as well as within-group analyses in HCs and PD separately. Between-group analyses will also be conducted between individuals with different ADORA2A genotypes.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Panic Disorder group (PD): Primary diagnosis of Panic Disorder.
- •Healthy control group (HCs): No current or history of psychiatric disorders.
- •All participants (PD and HCs): Weekly caffeine consumption ≤ 300 mg.
排除标准
- •Weekly caffeine consumption ≥ 300 mg.
- •Thoracic or head surgery, or any other surgery or metallic implanted devices not compatible with the safety standards for 7T MR scanner.
- •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 the 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 the 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 the 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 the 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
Task-related BOLD fMRI signal
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Self-reported anxiety
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Self-reported interoceptive awareness
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Self-reported interoceptive functional impairment
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Skin conductance responses (SCR)
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Occurrence of panic attacks
时间窗: Session 2 (day 2; minimum of 36 hours after session/day 1)
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
次要结局
- Heart rate variability(Session 2 (day 2; minimum of 36 hours after session/day 1))
- Structural brain data, T1-w sMRI(Session 2 (day 2; minimum of 36 hours after session/day 1))
- Respiratory rate(Session 2 (day 2; minimum of 36 hours after session/day 1))