The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories

March 31, 2023 updated by: Stefan Roepke, Charite University, Berlin, Germany

The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder

The purpose of the study is to examine whether oxytocin and certain polygenic risk scores affect the development of intrusive memories, a cardinal symptom of PTSD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10249
        • Charité- Universitätsmedizin Berlin

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • healthy female volunteers
  • German on a native level

Exclusion Criteria:

  • former or present disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
  • any physical illnesses
  • any medication intake (except oral contraceptive)
  • history of traumatic experience, e.g. history of sexual abuse or rape
  • pregnancy or lactation period
  • follicular phase of menstrual cycle for all women not using oral contraceptives

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin and trauma film paradigm
Intervention: Drug: Oxytocin nasal spray
Drug: Oxytocin
Drug: Oxytocin nasal spray
Placebo Comparator: Placebo and trauma film paradigm
Intervention: Drug: Placebos
Drug: Placebo
Drug: Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Intrusive Memories in the following four days after the intervention
Time Frame: four consecutive days
Influence of oxytocin on the development of intrusive memories measured with an intrusion diary
four consecutive days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Time Frame: Day 1
Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase
Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Time Frame: Day 1
Influence of oxytocin on the HPA-axis measured with salivary cortisol
Day 1
Polygenic Risk Score
Time Frame: four consecutive days
Influence of polygenic risk score on development of intrusive memories
four consecutive days

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Stefan Roepke, Prof, Charité

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)

March 6, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Charite2019-Oxytocin-Study

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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