Mood, Serotonin and Social Interaction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Empathic Accuracy
研究概览
简要总结
Rationale: Major depressive disorder (MDD) is a psychiatric disorder whose onset, severity, and duration are influenced by interpersonal factors. The serotonin system is known to influence MDD risk. Recent research has suggested that serotonin may also play a role in regulating social behaviour. Therefore, it would be interesting to study the role of serotonin in responses to social stimuli in individuals at risk for MDD.
Objective: This project aims to study how changes in serotonin alter interpersonal functioning in adults with or without a first degree family member diagnosed with MDD. The primary goal is to investigate the effect of experimentally lowered brain serotonin levels on empathic accuracy. Secondary goals are to determine how this manipulation influences verbal and non-verbal communication, cardiovascular function in a social context, and mood. An exploratory goal is to investigate how these outcomes are related to genes thought to be involved in MDD.
详细描述
see summary
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
- •Age 18 to 65 yrs
- •At least one first-degree family member with MDD, Family History (FH) positive, or no first and -second degree family members with MDD, FH negative
- •Willingness to cooperate, to sign written informed consent
排除标准
- •Any current or past Diagnostic and Statistical Manual (DSM) IV Axis I mood disorder, anxiety disorder, psychotic disorder, eating disorder, or somatoform disorder as determined by Structured Clinical Interview for DSM interview
- •Any current substance use disorder
- •Any past substance dependence
- •Ongoing medical treatment for a chronic disease, particularly cancer, gastrointestinal disease, phenylketonuria, diabetes, cardiovascular disease, or disease of the liver or kidneys
- •Not speaking Dutch fluently
- •Current or past use of neuroleptics, sedative drugs, antidepressants etc.
- •On test days, a positive urine test for drugs of abuse
- •For women, initiation of hormonal contraceptive treatments 3 months prior to screening, or a positive urine test for pregnancy on test days
研究组 & 干预措施
tryptophan depletion first day
tryptophan depletion on the first day. on the other day participants receive placebo.
干预措施: tryptophan depletion (Dietary Supplement)
tryptophan depletion on day 2
tryptophan depletion on the second day. on the first day participants receive placebo.
干预措施: tryptophan depletion (Dietary Supplement)
结局指标
主要结局
Empathic Accuracy
时间窗: 45 minutes
Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture
次要结局
- blood(10 minutes)
- Emotional Prosody (EP)(10 minutes)
- Behavioral mimicry(10 minutes)
- heart rate variability(1 hour)
研究者
Marije aan het Rot
Assistant Professor
University of Groningen