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Mood, Serotonin and Social Interaction

U

University of Groningen

Status and phase

Completed
Early Phase 1

Conditions

Social Behavior
Mood

Treatments

Dietary Supplement: tryptophan depletion

Study type

Interventional

Funder types

Other

Identifiers

NCT02051530
NL451-09-013

Details and patient eligibility

About

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.

Full description

see summary

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups

tryptophan depletion first day
Experimental group
Description:
tryptophan depletion on the first day. on the other day participants receive placebo.
Treatment:
Dietary Supplement: tryptophan depletion
tryptophan depletion on day 2
Experimental group
Description:
tryptophan depletion on the second day. on the first day participants receive placebo.
Treatment:
Dietary Supplement: tryptophan depletion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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