NCT02051530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.9 years

First QC Date

January 24, 2014

Last Update Submit

January 29, 2015

Conditions

MoodSocial Behavior

Keywords

moodempathymimicryemotional reactivityprosody

Outcome Measures

Primary Outcomes (1)

  • Empathic Accuracy

    Empathic Accuracy is assessed with a computer task, approximately 6 hrs after completion of the amino acid mixture

    45 minutes

Secondary Outcomes (4)

  • Behavioral mimicry

    10 minutes

  • Emotional Prosody (EP)

    10 minutes

  • blood

    10 minutes

  • heart rate variability

    1 hour

Other Outcomes (1)

  • Serotonin transporter polymorphism

    1 day

Study Arms (2)

tryptophan depletion first day

EXPERIMENTAL

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

Dietary Supplement: tryptophan depletion

tryptophan depletion on day 2

EXPERIMENTAL

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

Dietary Supplement: tryptophan depletion

Interventions

tryptophan depletionDIETARY_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 first daytryptophan depletion on day 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Center Psychiatry

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26462806DERIVED

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Marije aan het Rot, Dr.

    University of Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

April 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

NL(1)