NCT03426176

Brief Summary

the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

1.4 years

First QC Date

February 1, 2018

Last Update Submit

February 6, 2018

Conditions

Healthy

Keywords

oxytocinacute tryptophan depletionemotion

Outcome Measures

Primary Outcomes (2)

  • Neural processing during the emotion processing as assessed via fMRI

    fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups

    6h after treatment

  • Neural processing during the resting state as assessed via fMRI

    Resting state activity in the emotional brain networks will be compared between the treatment groups

    6h after treatment

Study Arms (4)

male oxytocin and ATD group

EXPERIMENTAL

male subjects receiving oxytocin and ATD treatment

Drug: oxytocin nasal sprayDrug: ATD treatment

male oxytocin and placebo group

EXPERIMENTAL

male subjects receiving oxytocin and ATD-placebo treatment

Drug: oxytocin nasal sprayDrug: oral placebo treatment (placebo-control for ATD)

male placebo and ATD group

EXPERIMENTAL

male subjects receiving oxytocin placebo and ATD treatment

Drug: intranasal placebo treatment (placebo-control for oxytocin)Drug: ATD treatment

male placebo group

PLACEBO COMPARATOR

male subjects receiving oxytocin placebo and ATD placebo treatment

Drug: intranasal placebo treatment (placebo-control for oxytocin)Drug: oral placebo treatment (placebo-control for ATD)

Interventions

oxytocin nasal sprayDRUG

intranasal administration of oxytocin (24 IU)

male oxytocin and ATD groupmale oxytocin and placebo group
intranasal placebo treatment (placebo-control for oxytocin)DRUG

intranasal administration of placebo nasal spray

male placebo and ATD groupmale placebo group
ATD treatmentDRUG

oral administration of ATD (75.2g) (Acute Tryptophan Depletion)

male oxytocin and ATD groupmale placebo and ATD group
oral placebo treatment (placebo-control for ATD)DRUG

oral administration of a tryptophan-balanced mixture (78.2g)

male oxytocin and placebo groupmale placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • health subjects without past or current psychiatric or neurological disorders
  • Right-handedness

You may not qualify if:

  • History of head injury;
  • Medical or psychiatric illness.
  • High blood pressure, general cardio-vascular alterations
  • History of drug or alcohol abuse or addiction.
  • Allergy against medications or general strong allergies
  • Sleep disorders.
  • Visual or motor impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life Science and Technology

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Benjamin Becker, Dr.

CONTACT

86-28-61830988ben_becker@gmx.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 8, 2018

Study Start

February 1, 2018

Primary Completion

June 15, 2019

Study Completion

July 15, 2019

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

CN(1)