Mood, Serotonin and Social Interaction

Early Phase 1

Completed

• Conditions: Mood; Social Behavior
• Interventions: Dietary Supplement: tryptophan depletion

• Registration Number: NCT02051530
• Lead Sponsor: University of Groningen

Brief Summary

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.

Detailed Description

see summary

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tryptophan depletion on day 2	tryptophan depletion	tryptophan depletion on the second day. on the first day participants receive placebo.
tryptophan depletion first day	tryptophan depletion	tryptophan depletion on the first day. on the other day participants receive placebo.

Primary Outcome Measures

Name	Time	Method
Empathic Accuracy	45 minutes	Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture

Secondary Outcome Measures

Name	Time	Method
blood	10 minutes	blood is analysed for levels of tryptophan, oxytocin and cortisol
Emotional Prosody (EP)	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.
Behavioral mimicry	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
heart rate variability	1 hour	hrv is measured in response to emotional video clips

Trial Locations

Locations (1)

University Center Psychiatry; 🇳🇱 Groningen, Netherlands