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CompletedNCT03031405Updated Aug 21, 2018

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

An interventional study of Oxytocin nasal spray and Placebos in Intrusive Memories, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.

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

Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 44 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Intrusive Memories
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 44 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
220 participants (actual)

Study arms

  • Experimental
    Oxytocin and trauma film paradigm

    Drug: Oxytocin nasal spray

  • Placebo comparator
    Placebo and trauma film paradigm

    Drug: Placebos

Interventions

  • DrugOxytocin nasal spray
  • DrugPlacebos

    Placebo nasal spray

06

What researchers measure

Primary outcomes

  1. Intrusive memories

    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. Genetic polymorphism

    Influence of genetic polymorphism of the oxytocin receptor on intrusive memories measured with an intrusion diary

    Time frame: four consecutive days

  3. 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

07

Study locations

1 site
  • Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
    Berlin, 12203, Germany
08

References and documents

Publications

  • 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. PubMed 34887528 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03031405
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Central Institute of Mental Health, Mannheim
Responsible party
Katharina Schultebraucks (PhD, Charite University, Berlin, Germany) — Principal investigator
First posted
Jan 25, 2017
Start date
Jan 15, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Aug 21, 2018

Study contacts

Stefan Roepke, PD Dr.
study director · Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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