Mood, Serotonin and Social Interaction

Mood Clinical Trial

Official title:

Mood, Serotonin and Social Interaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051530
• Other study ID #: NL451-09-013
• Status: Completed
• Phase: Phase 0
• First received: January 24, 2014
• Last updated: January 29, 2015
• Start date: April 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Description:

see summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Mood
• Social Behavior

Intervention

Dietary Supplement:
• tryptophan depletion
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

Locations

Country	Name	City	State
Netherlands	University Center Psychiatry	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serotonin transporter polymorphism	From one of the blood samples collected we will isolate whole blood for DNA extraction in order to analyse the serotonin transporter polymorphism	1 day	No
Primary	Empathic Accuracy	Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture	45 minutes	No
Secondary	Behavioral mimicry	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	10 minutes	No
Secondary	Emotional Prosody (EP)	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.	10 minutes	No
Secondary	blood	blood is analysed for levels of tryptophan, oxytocin and cortisol	10 minutes	No
Secondary	heart rate variability	hrv is measured in response to emotional video clips	1 hour	No