Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences

November 6, 2017 updated by: Prof. Robert Kumsta, Ruhr University of Bochum

Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.

In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxytocin
Single dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland)
Drug: Oxytocin
Other Names:
  • Syntocinon
Placebo Comparator: Placebo
All ingredients except for oxytocin.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading the Mind in the Eyes Test
Time Frame: 45 minutes post-dose
Requires participants to infer complex mental states fromthe eye region
45 minutes post-dose
Gradual Emotion Recognition Test
Time Frame: 50 minutes post-dose
Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.
50 minutes post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Collaborators

German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

March 23, 2013

Study Completion (Actual)

November 5, 2013

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

November 7, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU 2479/3-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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