Clinical trial NCT02051530: Mood, Serotonin and Social Interaction
Official title: Mood, Serotonin and Social Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mood
Social Behavior
Keywords: mood
empathy
mimicry
emotional reactivity
prosody
Lead sponsor: University of Groningen
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Empathic Accuracy
timeFrame: 45 minutes
Secondary outcomes:
measure: Behavioral mimicry
timeFrame: 10 minutes
measure: Emotional Prosody (EP)
timeFrame: 10 minutes
measure: blood
timeFrame: 10 minutes
measure: heart rate variability
timeFrame: 1 hour
Other outcomes:
measure: Serotonin transporter polymorphism
timeFrame: 1 day
Locations:
city: Groningen
country: Netherlands
facility: University Center Psychiatry
Study officials:
affiliation: University of Groningen
name: Marije aan het Rot, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hogenelst K, Schoevers RA, Kema IP, Sweep FC, aan het Rot M. Empathic accuracy and oxytocin after tryptophan depletion in adults at risk for depression. Psychopharmacology (Berl). 2016 Jan;233(1):111-20. doi: 10.1007/s00213-015-4093-9.