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OpenTrials
Completed

NCT Number: NCT02051530

Mood, Serotonin and Social Interaction

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.

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Key information

Conditions

Mood Behavior Social Behavior

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Center Psychiatry

Groningen, Provincie Groningen, 9713 GZ, Netherlands

About this study

see summary

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

tryptophan depletion

Dietary Supplement

tryptophan depletion involves the ingestion of an amino acid mixture that is devoid of tryptophan. on the other day participants receive placebo, being the same mixture but including tryptophan

Primary outcomes

  1. Empathic Accuracy

    Time frame: 45 minutes

    Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture

Secondary outcomes

  1. Behavioral mimicry

    Time frame: 10 minutes

    Behavioral mimicry is assessed in two experiments. In the first experiment, mimicry of a person in a video is assessed. In a second experiment mimicry is assessed in response to the investigators mannerisms

  2. Emotional Prosody (EP)

    Time frame: 10 minutes

    EP is assessed in two experiments. In the first experiment, EP is assessed in response to a video. In a second experiment EP is assessed in a dyad with the investigator.

  3. blood

    Time frame: 10 minutes

    blood is analysed for levels of tryptophan, oxytocin and cortisol

  4. heart rate variability

    Time frame: 1 hour

    hrv is measured in response to emotional video clips

Other outcomes

  1. Serotonin transporter polymorphism

    Time frame: 1 day

    From one of the blood samples collected we will isolate whole blood for DNA extraction in order to analyse the serotonin transporter polymorphism

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 31, 2014
Registry last updated
Jan 30, 2015

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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