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Mood, Serotonin and Social Interaction

NCT ID: NCT02051530

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-03-31

Brief Summary

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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

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see summary

Conditions

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Mood Social Behavior

Keywords

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mood empathy mimicry emotional reactivity prosody

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tryptophan depletion first day

tryptophan depletion on the first day. on the other day participants receive placebo.

Group Type EXPERIMENTAL

tryptophan depletion

Intervention Type 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

tryptophan depletion on day 2

tryptophan depletion on the second day. on the first day participants receive placebo.

Group Type EXPERIMENTAL

tryptophan depletion

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Groningen

OTHER

Sponsor Role lead

Responsible Party

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Marije aan het Rot

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marije aan het Rot, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Groningen

Locations

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University Center Psychiatry

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 26462806 (View on PubMed)

Other Identifiers

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NL451-09-013

Identifier Type: -

Identifier Source: org_study_id