Clinical trial NCT03425929: Oxytocin, Trauma Disclosure and Intrusions
Official title: Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: amygdala, fear, intrusion, oxytocin, trauma disclosure
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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) 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Total number of intrusions following the first trauma movie exposure.
timeFrame: Three days following the first trauma movie exposure.
measure: Total number of intrusions following the second trauma movie exposure.
timeFrame: Three days following the second trauma movie exposure.
measure: Neural responses to emotional faces in the amygdala.
timeFrame: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
measure: Neural responses to emotional faces in the prefrontal cortex.
timeFrame: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
measure: fMRI resting state data
timeFrame: Functional data will be acquired for 6 min.
measure: Trauma disclosure (time spend discussing the movie)
timeFrame: Six days following the first trauma movie exposure.
Secondary outcomes:
measure: Changes in pupil diameter in response to the trauma movie
timeFrame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
measure: Changes in skin conductance level in response to the trauma movie
timeFrame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
measure: Changes in respiration rate in response to the trauma movie
timeFrame: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
measure: Salivary oxytocin concentrations
timeFrame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
measure: Salivary cortisol concentrations
timeFrame: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
measure: Questionnaire measurement of mood (PANAS)
timeFrame: 10 min before and 10 min after the trauma movie.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
Study officials:
affiliation: University of Bonn
name: René Hurlemann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: