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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT03875391 (opens ClinicalTrials.gov in a new tab)Other idCharite2019-Oxytocin-Study
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
217 participants (actual)
Sponsor
Charite University, Berlin, Germany · Other
Design
Randomized · Triple masking
Countries
1 country

Germany

Start
6 Mar 2019
Primary completion
31 Dec 2020
Completion
31 Mar 2021
First posted
14 Mar 2019
Last update posted
4 Apr 2023
Conditions
Intrusive Memories · PTSD

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. N/A

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

    NCT03875391

    6 Mar 2019 to 31 Mar 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin and trauma film paradigm

    Intervention: Drug: Oxytocin nasal spray

  • Placebo comparator

    Placebo and trauma film paradigm

    Intervention: Drug: Placebos

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change of Intrusive Memories in the following four days after the intervention

    Time frame · four consecutive days

    Registry description

    Influence of oxytocin on the development of intrusive memories measured with an intrusion diary

Secondary outcomes(3)

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

    Time frame · Day 1

    Registry description

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

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

    Time frame · Day 1

    Registry description

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

  3. Polygenic Risk Score

    Time frame · four consecutive days

    Registry description

    Influence of polygenic risk score on development of intrusive memories

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

2 results

Oxytocin vs. placebo effects on intrusive memory consolidation using a trauma film paradigm: a randomized, controlled experimental study in healthy women.

Maslahati et al. 2023Translational psychiatrycited by 7

PMID 36739422PMC9899212DOI 10.1038/s41398-023-02339-zPUB-36739422

CC BY2 results
Download PDFSee results (2)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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