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

NCT ID: NCT03031405

Last Updated: 2018-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intrusive Memories

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxytocin and trauma film paradigm

Group Type EXPERIMENTAL

Oxytocin nasal spray

Intervention Type DRUG

Placebo and trauma film paradigm

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebo nasal spray

Interventions

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Oxytocin nasal spray

Intervention Type DRUG

Placebos

Placebo nasal spray

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Katharina Schultebraucks

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Roepke, PD Dr.

Role: STUDY_DIRECTOR

Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin

Locations

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Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin

Berlin, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34887528 (View on PubMed)

Other Identifiers

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Charite2017-Oxytocin-Study

Identifier Type: -

Identifier Source: org_study_id

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