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

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ClinicalTrials.gov Identifier: NCT03335085
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Prof. Robert Kumsta, Ruhr University of Bochum

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxytocin Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : March 23, 2013
Actual Study Completion Date : November 5, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: Oxytocin
Single dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland)
Drug: Oxytocin
Other Name: Syntocinon

Placebo Comparator: Placebo
All ingredients except for oxytocin.
Other: Placebo



Primary Outcome Measures :
  1. Reading the Mind in the Eyes Test [ Time Frame: 45 minutes post-dose ]
    Requires participants to infer complex mental states fromthe eye region

  2. Gradual Emotion Recognition Test [ Time Frame: 50 minutes post-dose ]
    Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Robert Kumsta, Professor of Genetic Psychology, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT03335085    
Other Study ID Numbers: KU 2479/3-1
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs