NCT03875391

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

March 11, 2019

Last Update Submit

March 31, 2023

Conditions

Intrusive MemoriesPTSD

Outcome Measures

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

    four consecutive days

Secondary Outcomes (3)

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

    Day 1

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

    Day 1

  • Polygenic Risk Score

    four consecutive days

Study Arms (2)

Oxytocin and trauma film paradigm

EXPERIMENTAL

Intervention: Drug: Oxytocin nasal spray

Drug: Oxytocin

Placebo and trauma film paradigm

PLACEBO COMPARATOR

Intervention: Drug: Placebos

Drug: Placebo

Interventions

OxytocinDRUG

Drug: Oxytocin nasal spray

Oxytocin and trauma film paradigm
PlaceboDRUG

Drug: Placebo nasal spray

Placebo and trauma film paradigm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Berlin, 10249, Germany

Location

Related Publications (1)

  • Maslahati T, Wingenfeld K, Hellmann-Regen J, Kraft J, Lyu J, Keinert M, Voss A, Cho AB, Ripke S, Otte C, Schultebraucks K, Roepke S. Oxytocin vs. placebo effects on intrusive memory consolidation using a trauma film paradigm: a randomized, controlled experimental study in healthy women. Transl Psychiatry. 2023 Feb 4;13(1):42. doi: 10.1038/s41398-023-02339-z.

    PMID: 36739422DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Stefan Roepke, Prof

    Charité

    PRINCIPAL INVESTIGATOR

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
Principal Investigator, PD Dr.

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 14, 2019

Study Start

March 6, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

April 4, 2023

Record last verified: 2022-04

Locations

DE(1)