Oxytocin, Trauma Disclosure and Intrusions

NCT03425929 | Completed Phase 1

• 1 other identifier: PROXY
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

amygdala, fear, intrusion, oxytocin, trauma disclosure

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Six days following the first trauma movie exposure.

Secondary Outcomes (6)

• Changes in pupil diameter in response to the trauma movie

  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

  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

  2 min baseline before the trauma movie and during 15 min of the trauma movie.

• Salivary oxytocin concentrations

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

• Salivary cortisol concentrations

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

Study Arms (3)

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)

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Placebo nasal spray for six days

Drug: Placebo

Interventions

Oxytocin DRUG

Intranasal administration, 24 international units (IU) oxytocin.

Also known as: syntocinon

Oxytocin (3 days); Oxytocin (6 days)

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female volunteers
• Right-handed

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, 53105, Germany

Location

Related Links

• Neuromodulation of Emotion (NEMO) research group

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• René Hurlemann, MD, PhD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 8, 2018
• Study Start: June 1, 2016
• Primary Completion: March 18, 2017
• Study Completion: March 18, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)