Intrusive MemoriesNCT03875391
The Effect of Oxytocin on the Consolidation of Trauma-Associated Memories
A study testing Oxytocin in people with Intrusive Memories and PTSD, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories, PTSD
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- 1 siteGermany
- Study dates
- 6 Mar 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy female volunteers
- German on a native level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
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.
- Conditions
- Intrusive Memories, PTSD
- Being tested
- Oxytocin, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Drug: Oxytocin nasal spray
PlaceboDrug
Drug: Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin and trauma film paradigm | Experimental | Intervention: Drug: Oxytocin nasal spray Receives: Drug: Oxytocin |
| Placebo and trauma film paradigm | Placebo comparator | Intervention: Drug: Placebos Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: four consecutive days
Secondary outcomes (3)
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Influence of oxytocin on the noradrenergic system measured with salivary alpha-amylase
Measured: Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Influence of oxytocin on the HPA-axis measured with salivary cortisol
Measured: Day 1
Polygenic Risk Score
Influence of polygenic risk score on development of intrusive memories
Measured: four consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start6 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrusive MemoriesStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Roepke, Charite University, Berlin, Germany
- Investigators
- Stefan Roepke, Prof, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875391
- Sponsor's protocol ID
- Charite2019-Oxytocin-Study
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36739422
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin on the Acquisition and Consolidation of Trauma-Associated Memories: A Model to Understand the Development of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03875391
- Acronym / sponsor ID
- Charite2019-Oxytocin-Study
- Conditions
- Intrusive Memories, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin and trauma film paradigm | Experimental | Drug: OxytocinIntervention: Drug: Oxytocin nasal spray |
| Placebo and trauma film paradigm | Placebo comparator | Drug: PlaceboIntervention: Drug: Placebos |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy female volunteers
- German on a native level
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinDrug: Oxytocin nasal spray | Drug | Oxytocin and trauma film paradigm |
| PlaceboDrug: Placebo nasal spray | Drug | Placebo and trauma film paradigm |
Primary outcome
Change of Intrusive Memories in the following four days after the intervention
Time frame: four consecutive days
Influence of oxytocin on the development of intrusive memories measured with an intrusion diary
3 secondary outcomes
Noradrenergic System (measured with salivary alpha-amylase - u/ml)
Time frame: Day 1
Hypothalamic-pituitary-adrenal (HPA) axis (measured with salivary cortisol - nmol/L)
Time frame: Day 1
Polygenic Risk Score
Time frame: four consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 36739422Maslahati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Roepke, Prof principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Intrusive Memories and PTSD, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Intrusive Memories in the following four days after the intervention (time frame: four consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.