The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories
1 other identifier
interventional
220
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2017
CompletedFirst Submitted
Initial submission to the registry
January 18, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedAugust 21, 2018
January 1, 2017
1.5 years
January 18, 2017
August 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Intrusive memories
Influence of oxytocin on the development of intrusive memories measured with an intrusion diary
four consecutive days
Secondary Outcomes (3)
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Day 1
Genetic polymorphism
four consecutive days
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Day 1
Study Arms (2)
Oxytocin and trauma film paradigm
EXPERIMENTALPlacebo and trauma film paradigm
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- healthy female volunteers
- German on a native level
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Berlin, 12203, Germany
Related Publications (1)
Schultebraucks K, Maslahati T, Wingenfeld K, Hellmann-Regen J, Kraft J, Kownatzki M, Behnia B, Ripke S, Otte C, Roepke S. Intranasal oxytocin administration impacts the acquisition and consolidation of trauma-associated memories: a double-blind randomized placebo-controlled experimental study in healthy women. Neuropsychopharmacology. 2022 Apr;47(5):1046-1054. doi: 10.1038/s41386-021-01247-4. Epub 2021 Dec 9.
PMID: 34887528DERIVED
Study Officials
- STUDY DIRECTOR
Stefan Roepke, PD Dr.
Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 18, 2017
First Posted
January 25, 2017
Study Start
January 15, 2017
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
August 21, 2018
Record last verified: 2017-01