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Completed

NCT Number: NCT03875391

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

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.

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Key information

Conditions

Intrusive Memories Mental Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charité- Universitätsmedizin Berlin

Berlin, 10249, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Drug: Oxytocin nasal spray

Placebo

Drug

Drug: Placebo nasal spray

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Polygenic Risk Score

    Time frame: four consecutive days

    Influence of polygenic risk score on development of intrusive memories

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 14, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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