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临床试验/NCT02051569
NCT02051569已完成早期 1 期

Everyday Social Behavior and Mood in Individuals With a Family History of Depression. Investigating the Role of Serotonin

University of Groningen0 个研究点目标入组 40 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
40
主要终点
quarrelsome behaviour

研究概览

简要总结

Rationale: Poor social functioning may contribute to major depressive disorder (MDD). Poor serotonin function may also contribute to MDD. Recent research suggests that serotonin plays a role in regulating human social behaviour. Therefore it would be intriguing to investigate the role of serotonin in regulating the quality of everyday social interactions in a population at risk for MDD. Human social behaviour can be reliably assessed in everyday life using Ecological Momentary Assessment (EMA).

Objective: This study aims to investigate how an experimental increase in serotonin influences social functioning in healthy adults with a first-degree family member diagnosed with MDD. The primary goal is to investigate the role of serotonin in regulating everyday social behaviour, measured using EMA. This will be done using oral supplementation with tryptophan, the amino acid precursor of serotonin. Secondary goals are to determine how this experimental manipulation influences people's feelings as well as their perceptions of other's social behaviour following interpersonal events, and social cognitions at the end of the day. An exploratory goal is to investigate if these effects are moderated by genes thought to be involved in MDD.

The primary hypothesis to be tested is that tryptophan will reduce quarrelsome behaviour.

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

入选标准

  • Age 18-65 years
  • At least one first-degree family member with MDD
  • Willingness to cooperate; to sign written informed consent

排除标准

  • Any current or past MDD or other mood disorder as determined by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID)
  • Any current anxiety disorder, psychotic disorder, substance use disorder, eating disorder, or somatoform disorder as determined by SCID
  • Any contraindication for the use of tryptophan, i.e. pregnancy, diabetes, cancer or a history of cancer, a history of any scleroderma-like condition, evidence of achlorhydria, upper bowel malabsorption, or irritation of the urinary bladder
  • Current use of psychotropic medications including medications for psychiatric problems (e.g., antidepressants such as Mono Amine Oxidase inhibitors and fluoxetine) or migraines
  • Not speaking Dutch fluently

结局指标

主要结局

quarrelsome behaviour

时间窗: 28 days

quarrelsome behaviour is measured daily for 28 days using Ecological Momentary Assessment.

次要结局

  • interpersonal behaviour(28 days)
  • affect(28 days)
  • perceptions of others(28 days)
  • social cognitions(28 days)

研究者

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

Marije aan het Rot

Assistant Professor

University of Groningen

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Serotonin and Everyday Social Interaction | 临床试验