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CompletedNCT03875391Updated Apr 4, 2023

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

An interventional study of Oxytocin and Placebo in Intrusive Memories and PTSD, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
217
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrusive Memories
  • PTSD
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy female volunteers
  • German on a native level

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
217 participants (actual)

Study arms

  • Experimental
    Oxytocin and trauma film paradigm

    Intervention: Drug: Oxytocin nasal spray

    Drug: Oxytocin

  • Placebo comparator
    Placebo and trauma film paradigm

    Intervention: Drug: Placebos

    Drug: Placebo

Interventions

  • DrugOxytocin

    Drug: Oxytocin nasal spray

  • DrugPlacebo

    Drug: Placebo nasal spray

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: four consecutive days

Secondary outcomes

  1. Noradrenergic System (measured with salivary alpha-amylase - u/ml)

    Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase

    Time frame: Day 1

  2. Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)

    Influence of oxytocin on the HPA-axis measured with salivary cortisol

    Time frame: Day 1

  3. Polygenic Risk Score

    Influence of polygenic risk score on development of intrusive memories

    Time frame: four consecutive days

07

Study locations

1 site
  • Charité- Universitätsmedizin Berlin
    Berlin, 10249, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03875391
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Stefan Roepke (Principal Investigator, PD Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Mar 14, 2019
Start date
Mar 6, 2019
Primary completion
Dec 31, 2020
Completion
Mar 31, 2021
Last update
Apr 4, 2023

Study contacts

Stefan Roepke, Prof
principal investigator · Charité

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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