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临床试验/NCT05208294
NCT05208294已完成不适用

The Role of Dopamine, Reward Learning and Prefrontal Activity in Expectation-induced Mood Enhancement

Philipps University Marburg Medical Center1 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2021年12月9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
297
试验地点
1
主要终点
The probabilistic reinforcement learning task

研究概览

简要总结

Although placebo effects on depressive symptoms are well documented, the underlying mechanisms and moderating factors of expectation effects on mood and depression are poorly understood. Various studies show reduced reward processing in clinical and subclinical depression, presumably due to abnormalities in the dopamine (DA) system. Here, the investigators will test whether expectation-induced mood enhancement is mediated by endogenous DA activity and reward learning, and moderated by individual differences in depression-related personality traits. Healthy participants (N=296) will be tested for potentially relevant personality traits and given an inactive substance (placebo) or a DA D2-receptor antagonist sulpiride (400 mg) in combination with a low vs. high expectation manipulation (fully crossed 2x2 placebo design) before performing a probabilistic reinforcement learning task, an effort expenditure task, and undergo a depressed mood induction procedure. Further, EEG indices will be assessed throughout the tasks.

The investigators expect that positive expectation improves participants' reinforcement learning, increases participants' willingness to make effort in order to obtain reward, and leads to less depressive symptoms as indicated by mood ratings upon depressive mood induction. If the overall effect of positive expectations is mediated by DA, high-dose sulpiride should block expectation-induced effects, i.e., the anticipated enhanced reinforcement learning and effort expenditure as well as mood improvement in the high vs. low expectation group.

详细描述

The placebo effect, i.e., raising expectations towards a successful treatment by applying an inactive substance, reportedly improves therapeutic outcomes in clinical trials. Although there is supporting evidence for the neurotransmitter dopamine (DA) and reinforcement learning, i.e. learning from reward and punishment, to mediate this effect, to the knowledge of the authors, no study has tested these underpinnings yet. The objective of the present project is to investigate whether expectation-induced mood enhancement is mediated by DA activity and reward learning, and moderated by individual differences in depression-related personality traits. To this end, participants will be told to either receive a placebo (low expectation) or a medicine which is labeled as antidepressant (high expectation) that improves mood. Orthogonal to this expectation manipulation, participants actually receive either 400 mg of sulpiride (sulpiride group) or a placebo (inactive substance group). Sulpiride is a selective D2-recptor antagonist which presumably elevates DA levels in low doses and has been used as an antidepressant. However, as a part of the high expectation group's expectation manipulation, while participants are told to receive an antidepressant, the sulpiride group actually receives a dose that is presumably too high to increase DA levels and produce antidepressant effects. Rather, 400mg of sulpirid presumably leads to a blockade of dopamine receptors and may thereby block expectation placebo effects. Participants then undergo three tasks, in which behavioral and computational markers of reinforcement learning and willingness to make effort in order to obtain reward are investigated. Further, mood ratings upon depressive mood induction will be assessed. In addition to participants behavioral responses, EEG indices will be recorded throughout the tasks. Prior to testing, participants will be asked to fill out questionnaires with regard to personality traits as well as reward response. In order to assess dopamine-related plasma prolactin, the study physician will draw one blood sample (ca. 8 ml) at the beginning of the testing session (at approximately 9 a.m.) and one hour after substance intake (at approximately 10 a.m.), which presumably corresponds with the latency of the peak of the prolactin response to sulpiride. Saliva and gene samples will be collected for hypotheses that are tested in the context of the overarching collaborative research center 289 and preregistered elsewhere.

It is expected that positive expectation improves participants' reinforcement learning, increases participants' willingness to make effort in order to obtain reward, and leads to less depressive symptoms as indicated by mood ratings upon depressive mood induction. If the overall effect of positive expectations is mediated by DA, high-dose sulpiride should block expectation-induced effects, i.e., the anticipated enhanced reinforcement learning and effort expenditure as well as mood improvement in the high vs. low expectation group.

Hypotheses:

  1. Expectation enhancement (high vs. low) within the placebo group is associated with lower negative mood ratings after the mood induction procedure.
  2. Expectation enhancement (high vs. low) within the placebo group enhances computationally modeled reward learning parameters and EEG markers of reward processing during the reinforcement learning task.
  3. Within the placebo group, the expectation effect on negative mood ratings mentioned in (1) is correlated with the expectation effect on reward learning parameters in the probabilistic reinforcement learning task mentioned in (2).
  4. Across the two expectation groups and within the placebo group, reward learning parameters and electrophysiological markers of reward processing are positively correlated with questionnaire measures of agentic extraversion (and negatively with self-reported depressive symptoms).
  5. In the sulpiride group, the effects described in (1), (2), and (3) are lower than in the placebo group.
  6. The prolactin response to sulpiride is correlated with the magnitude of expectation effects on reinforcement learning, negative mood, and self-reported agentic extraversion as well as depressive symptoms.
  7. High levels of the personality trait agentic extraversion (and low levels of depressive symptoms) are associated with higher expectancy effects on negative mood.

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, Investigator, Outcomes Assessor)

盲法说明

Participants will be blinded to the actual substance groups. In order to carry out the expectation manipulation, the clinician scientists will provide participants with substance information that is unrelated to the actual substance that is received by the participants. Hence the clinician scientists are blind to the actual substance (double blind design). Other than providing (invalid) substance information (i.e. the expectation manipulation) and drawing blood samples, the study clinicians do not take part in the remaining experimental procedure. The investigators who accompany participants throughout the experimental procedure are not aware of participants' true substance and expectation allocation.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handed
  • Aged 18-60 years
  • German native speaker
  • Informed consent
  • Normal or corrected sight

排除标准

  • Current pregnancy
  • Current or history of general medical, neurological or psychological disorders, which preclude sulpiride intake
  • Self-reported presence of mental disorders
  • Liver, kidney, and bowel disorders
  • Regular smoking
  • Reported alcohol abuse
  • Illegal drug intake
  • Regular drug intake by prescription in the past three months
  • Dreadlocks
  • BMI < 19 or > 30
  • Unremovable metal objects around the head
  • Previous knowledge of Japanese characters
  • Excessive caffeine intake (> 8 cups per day)

研究组 & 干预措施

High expectation with sulpiride group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an antidepressant sulpiride capsule is administrated, while participants actually receive a sulpiride 400mg-capsule (note that the dose is presumably too high to produce antidepressant effects).

干预措施: Sulpiride 400 MG (Drug)

High expectation with sulpiride group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an antidepressant sulpiride capsule is administrated, while participants actually receive a sulpiride 400mg-capsule (note that the dose is presumably too high to produce antidepressant effects).

干预措施: High expectation manipulation (Behavioral)

High expectation with placebo group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an antidepressant sulpiride capsule is administrated, while participants actually receive a placebo capsule.

干预措施: Placebo (Drug)

High expectation with placebo group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an antidepressant sulpiride capsule is administrated, while participants actually receive a placebo capsule.

干预措施: High expectation manipulation (Behavioral)

Low expectation with sulpiride group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an inactive placebo capsule is administrated, while participants actually receive a sulpiride capsule (400 mg).

干预措施: Sulpiride 400 MG (Drug)

Low expectation with sulpiride group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an inactive placebo capsule is administrated, while participants actually receive a sulpiride capsule (400 mg).

干预措施: Low expectation manipulation (Behavioral)

Low expectation with placebo group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an inactive placebo capsule is administrated, and participants actually receive a placebo capsule.

干预措施: Placebo (Drug)

Low expectation with placebo group

Experimental

Prior to the experimental procedure, participants are told by the study clinicians that an inactive placebo capsule is administrated, and participants actually receive a placebo capsule.

干预措施: Low expectation manipulation (Behavioral)

结局指标

主要结局

The probabilistic reinforcement learning task

时间窗: This will be the first task participants undergo approximately 3 hours after treatment (i.e., substance intake) followed by the two other tasks.

With regard to probabilistic reinforcement learning: participants' reward learning rate parameter αG as estimated in computational modeling.

The Positive and Negative Affect Schedule (PANAS)

时间窗: Five time points: approximately 3 hours after treatment (i.e., substance intake), approximately 4 hours after treatment, approximately 4.5 hours after treatment, approximately 4.75 hours after treatment, and approximately 5 hours after treatment.

With regard to depressive mood induction: the mean of participants' five mood ratings during and immediately after the mood induction procedure. Participants' current mood will be rated on a 5-point Likert scale ranging from 1 = very slightly or not at all to 5 = extremely.

The Effort Expenditure for Rewards Task (EEfRT)

时间窗: This will be the second task participants undergo which follows the probabilistic reinforcement learning task (approximately 4 hours after treatment) followed by the mood induction procedure.

With regard to effort expenditure: The number of participants' choices for the hard task which required more effort.

次要结局

  • EEG responses to reward feedback(Approximately 3 hours after treatment (i.e., simultaneously during the probabilistic reinforcement learning task).)
  • Mood ratings(Simultaneously as PANAS (see primary outcome 1).)
  • EEG responses to mood induction(Approximately 4. 5 hours after treatment (i.e., during the mood induction procedure which follows the probabilistic reinforcement learning task and the EEfRT tasks).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik Müller

Professor of Personality Psychology

Philipps University Marburg Medical Center

研究点 (1)

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