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OpenTrials
Completed

NCT Number: NCT02051569

Serotonin and Everyday Social Interaction

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.

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Key information

Conditions

Social Behaviour Behavior Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

TRYPTOPHAN

Dietary Supplement

Tryptophan and placebo are given in a crossover design, based on randomisation.

Primary outcomes

  1. quarrelsome behaviour

    Time frame: 28 days

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

Secondary outcomes

  1. interpersonal behaviour

    Time frame: 28 days

    measures are assessed on a daily basis for 28 days with ecological momentary assessment

  2. affect

    Time frame: 28 days

    measures are assessed on a daily basis for 28 days with ecological momentary assessment

  3. perceptions of others

    Time frame: 28 days

    measures are assessed on a daily basis for 28 days with ecological momentary assessment

  4. social cognitions

    Time frame: 28 days

    measures are assessed daily for 28 days with ecological momentary assessment

Other outcomes

  1. Serotonin transporter polymorphism

    Time frame: 1 day

    Prior to starting the 28 days of social interacton recording participants are instructed about the study procedures. The saliva samples are analyzed for Serotonin transporter polymorphism.

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2014
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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