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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2021

Interventions

  • Drug: Oxytocin
    • Drug: Oxytocin nasal spray
  • Drug: Placebo
    • Drug: Placebo nasal spray

Arms, Groups and Cohorts

  • Experimental: Oxytocin and trauma film paradigm
    • Intervention: Drug: Oxytocin nasal spray
  • Placebo Comparator: Placebo and trauma film paradigm
    • Intervention: Drug: Placebos

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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
  • Polygenic Risk Score
    • Time Frame: four consecutive days
    • Influence of polygenic risk score on development of intrusive memories

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stefan Roepke, Principal Investigator, PD Dr. – Charite University, Berlin, Germany
  • Overall Official(s)
    • Stefan Roepke, Prof, Principal Investigator, Charité
  • Overall Contact(s)
    • Tolou Maslahati, M.Sc., 0049 030 450 517 567, tolou.maslahati@charite.de

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