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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03875391
• Other study ID #: Charite2019-Oxytocin-Study
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrusive Memories
• PTSD

Intervention

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

Locations

Country	Name	City	State
Germany	Charité- Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Intrusive Memories in the following four days after the intervention	Influence of oxytocin on the development of intrusive memories measured with an intrusion diary	four consecutive days
Secondary	Noradrenergic System (measured with salivary alpha-amylase - u/ml)	Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase	Day 1
Secondary	Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)	Influence of oxytocin on the HPA-axis measured with salivary cortisol	Day 1
Secondary	Polygenic Risk Score	Influence of polygenic risk score on development of intrusive memories	four consecutive days