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Completed

NCT Number: NCT03425929

Oxytocin, Trauma Disclosure and Intrusions

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female volunteers
  • Right-handed

Exclusion criteria

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Hormonal contraception
  • MRI contraindication (e.g. metal in body, claustrophobia)

Treatment and study plan

Oxytocin

Drug

Intranasal administration, 24 international units (IU) oxytocin.

Other names: syntocinon

Placebo

Drug

The placebo nasal sprays contain identical ingredients except for the peptide itself.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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 pupil diameter will be measured.

  2. 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 skin conductance level will be measured.

  3. 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.

    Changes in respiration rate will be measured.

  4. Salivary oxytocin concentrations

    Time frame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.

    Saliva samples will be collected before and after the trauma movie to assess changes in oxytocin concentrations.

  5. Salivary cortisol concentrations

    Time frame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.

    Saliva samples will be collected before and after the trauma movie to assess changes in cortisol concentrations.

  6. Questionnaire measurement of mood (PANAS)

    Time frame: 10 min before and 10 min after the trauma movie.

    Positive and negative affect will be assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2018
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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