HealthyPhase 1NCT03425929
Oxytocin, Trauma Disclosure and Intrusions
A Phase 1 study testing Oxytocin in people with Healthy, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy 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
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2016to 18 Mar 2017
- Phase
- Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female volunteers
- Right-handed
Who cannot join
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Hormonal contraception
- MRI contraindication (e.g. metal in body, claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects. Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience. Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.
Read the detailed description
Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study. After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Intranasal administration, 24 international units (IU) oxytocin.
PlaceboDrug
The placebo nasal sprays contain identical ingredients except for the peptide itself.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin (6 days) | Active comparator | Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day) Receives: Drug: Oxytocin |
| Oxytocin (3 days) | Active comparator | Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Placebo nasal spray for six days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of intrusions following the first trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
Measured: Three days following the first trauma movie exposure.
Total number of intrusions following the second trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
Measured: Three days following the second trauma movie exposure.
Neural responses to emotional faces in the amygdala.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
Measured: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
Neural responses to emotional faces in the prefrontal cortex.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
Measured: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
fMRI resting state data
Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular.
Measured: Functional data will be acquired for 6 min.
Trauma disclosure (time spend discussing the movie)
The intrusion diaries will contain a question for how long participants discussed the trauma movie.
Measured: Six days following the first trauma movie exposure.
Secondary outcomes (6)
Changes in pupil diameter in response to the trauma movie
Changes in pupil diameter will be measured.
Measured: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in skin conductance level in response to the trauma movie
Changes in skin conductance level will be measured.
Measured: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in respiration rate in response to the trauma movie
Changes in respiration rate will be measured.
Measured: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Salivary oxytocin concentrations
Saliva samples will be collected before and after the trauma movie to assess changes in oxytocin concentrations.
Measured: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Salivary cortisol concentrations
Saliva samples will be collected before and after the trauma movie to assess changes in cortisol concentrations.
Measured: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Questionnaire measurement of mood (PANAS)
Positive and negative affect will be assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
Measured: 10 min before and 10 min after the trauma movie.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Jun 2016
- Primary completion18 Mar 2017
- Study completion18 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
- Investigators
- René Hurlemann, MD, PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425929
- Sponsor's protocol ID
- PROXY
- Status last verified
- Feb 2018
- First submitted
- 28 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
- ClinicalTrials.gov ID
- NCT03425929
- Acronym / sponsor ID
- PROXY
- Conditions
- Healthy
- Keywords
- amygdala, fear, intrusion, oxytocin, trauma disclosure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 18 Mar 2017 (actual)
- Study completion
- 18 Mar 2017 (actual)
- First posted
- 8 Feb 2018 (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.
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects. Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience. Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.
Detailed description
Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study. After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin (6 days) | Active comparator | Drug: OxytocinIntranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day) |
| Oxytocin (3 days) | Active comparator | Drug: OxytocinIntranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo nasal spray for six days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female volunteers
- Right-handed
Key exclusion criteria (5 listed)
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Hormonal contraception
- MRI contraindication (e.g. metal in body, claustrophobia)
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: syntocinonIntranasal administration, 24 international units (IU) oxytocin. | Drug | Oxytocin (3 days), Oxytocin (6 days) |
| PlaceboThe placebo nasal sprays contain identical ingredients except for the peptide itself. | Drug | Placebo |
Primary outcome
Total number of intrusions following the first trauma movie exposure.
Time frame: Three days following the first trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
Total number of intrusions following the second trauma movie exposure.
Time frame: Three days following the second trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
Neural responses to emotional faces in the amygdala.
Time frame: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
Neural responses to emotional faces in the prefrontal cortex.
Time frame: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
fMRI resting state data
Time frame: Functional data will be acquired for 6 min.
Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular.
Trauma disclosure (time spend discussing the movie)
Time frame: Six days following the first trauma movie exposure.
The intrusion diaries will contain a question for how long participants discussed the trauma movie.
6 secondary outcomes
Changes in pupil diameter in response to the trauma movie
Time frame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in skin conductance level in response to the trauma movie
Time frame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in respiration rate in response to the trauma movie
Time frame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Salivary oxytocin concentrations
Time frame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Salivary cortisol concentrations
Time frame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Questionnaire measurement of mood (PANAS)
Time frame: 10 min before and 10 min after the trauma movie.
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 8 Feb 2018.
- Neuromodulation of Emotion (NEMO) research groupLink provided by the sponsor.
- 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.
René Hurlemann, MD, PhD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Healthy, run by University Hospital, Bonn 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 5 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 8 Feb 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total number of intrusions following the first trauma movie exposure. (time frame: Three days following the first trauma movie exposure.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2018.