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

Intrusive Memories 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: NCT03031405
• Other study ID #: Charite2017-Oxytocin-Study
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2017
• 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 oxytocin receptor gene polymorphism affect the development of intrusive memories, a cardinal symptom of PTSD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 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

Intervention

Drug:
• Oxytocin nasal spray

• Placebos
Placebo nasal spray

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrusive memories	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	Genetic polymorphism	Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary	four consecutive days
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