NCT03335085

Brief Summary

This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable healthy

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

July 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.7 years

First QC Date

November 3, 2017

Last Update Submit

November 6, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Reading the Mind in the Eyes Test

    Requires participants to infer complex mental states fromthe eye region

    45 minutes post-dose

  • Gradual Emotion Recognition Test

    Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.

    50 minutes post-dose

Study Arms (2)

Oxytocin

ACTIVE COMPARATOR

Single dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland)

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

All ingredients except for oxytocin.

Other: Placebo

Interventions

OxytocinDRUG
Also known as: Syntocinon
Oxytocin
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • presence of moderate to severe experiences of childhood adversity (early adversity group)

You may not qualify if:

  • Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Schwaiger M, Heinrichs M, Kumsta R. Oxytocin administration and emotion recognition abilities in adults with a history of childhood adversity. Psychoneuroendocrinology. 2019 Jan;99:66-71. doi: 10.1016/j.psyneuen.2018.08.025. Epub 2018 Aug 27.

    PMID: 30189345DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

July 1, 2011

Primary Completion

March 23, 2013

Study Completion

November 5, 2013

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share