HealthyNCT03335085
Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences
A study testing Oxytocin in people with Healthy, run by Ruhr University of Bochum.
Trial summary
This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2011to 5 Nov 2013
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- presence of moderate to severe experiences of childhood adversity (early adversity group)
Who cannot join
- Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
- Pregnancy
About this study
Official title: Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models
This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.
Read the detailed description
Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.
In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Single dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland) Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | All ingredients except for oxytocin. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading the Mind in the Eyes Test
Requires participants to infer complex mental states fromthe eye region
Measured: 45 minutes post-dose
Gradual Emotion Recognition Test
Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.
Measured: 50 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Jul 2011
- Primary completion23 Mar 2013
- Study completion5 Nov 2013
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 HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Prof. Robert Kumsta, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335085
- Sponsor's protocol ID
- KU 2479/3-1
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwaiger M, Heinrichs M, Kumsta R. Oxytocin administration and emotion recognition abilities in adults with a history of childhood adversity. Psychoneuroendocrinology. 2019 Jan;99:66-71. doi: 10.1016/j.psyneuen.2018.08.025. Epub 2018 Aug 27.
PubMed 30189345
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models
- ClinicalTrials.gov ID
- NCT03335085
- Acronym / sponsor ID
- KU 2479/3-1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 23 Mar 2013 (actual)
- Study completion
- 5 Nov 2013 (actual)
- First posted
- 7 Nov 2017 (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.
This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.
Detailed description
Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.
In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinSingle dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland) |
| Placebo | Placebo comparator | Other: PlaceboAll ingredients except for oxytocin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- presence of moderate to severe experiences of childhood adversity (early adversity group)
Key exclusion criteria (2 listed)
- Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
- Pregnancy
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 |
|---|---|---|
| OxytocinAlso: Syntocinon | Drug | Oxytocin |
| Placebo | Other | Placebo |
Primary outcome
Reading the Mind in the Eyes Test
Time frame: 45 minutes post-dose
Requires participants to infer complex mental states fromthe eye region
Gradual Emotion Recognition Test
Time frame: 50 minutes post-dose
Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.
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 7 Nov 2017.
- Derived from this study: PubMed 30189345Schwaiger M, Heinrichs M, Kumsta R. Oxytocin administration and emotion recognition abilities in adults with a history of childhood adversity. Psychoneuroendocrinology. 2019 Jan;99:66-71. doi: 10.1016/j.psyneuen.2018.08.025. Epub 2018 Aug 27.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Healthy, run by Ruhr University of Bochum.
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 1 inclusion and 2 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Reading the Mind in the Eyes Test (time frame: 45 minutes post-dose). The study lists 2 primary outcomes in all. 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 NCT03335085, 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 7 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.