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

Not Applicable

Completed

• Conditions: Intrusive Memories; PTSD
• Interventions: Drug: Placebo; Drug: Oxytocin

• Registration Number: NCT03875391
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31
• Status Verified: 2022-04
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 217

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo and trauma film paradigm	Placebo	Intervention: Drug: Placebos
Oxytocin and trauma film paradigm	Oxytocin	Intervention: Drug: Oxytocin nasal spray

Primary Outcome Measures

Name	Time	Method
Change of Intrusive Memories in the following four days after the intervention	four consecutive days	Influence of oxytocin on the development of intrusive memories measured with an intrusion diary

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité- Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany