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Oxytocin, Trauma Disclosure and Intrusions

1 februari 2018 uppdaterad av: Rene Hurlemann, University Hospital, Bonn

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

70

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Tyskland
      • Bonn, Tyskland, 53105
        • Department of Psychiatry, University of Bonn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 40 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Oxytocin (6 days)
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)
Läkemedel: Oxytocin
Intranasal administration, 24 international units (IU) oxytocin.
Andra namn:
  • syntocinon
Aktiv komparator: Oxytocin (3 days)
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
Läkemedel: Oxytocin
Intranasal administration, 24 international units (IU) oxytocin.
Andra namn:
  • syntocinon
Placebo-jämförare: Placebo
Placebo nasal spray for six days
Läkemedel: Placebo
Placebo-nässprayerna innehåller identiska ingredienser förutom själva peptiden.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Total number of intrusions following the first trauma movie exposure.
Tidsram: 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.
Three days following the first trauma movie exposure.
Total number of intrusions following the second trauma movie exposure.
Tidsram: 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.
Three days following the second trauma movie exposure.
Neural responses to emotional faces in the amygdala.
Tidsram: 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 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.
Tidsram: 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.
Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
fMRI resting state data
Tidsram: 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.
Functional data will be acquired for 6 min.
Trauma disclosure (time spend discussing the movie)
Tidsram: Six days following the first trauma movie exposure.
The intrusion diaries will contain a question for how long participants discussed the trauma movie.
Six days following the first trauma movie exposure.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in pupil diameter in response to the trauma movie
Tidsram: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in pupil diameter will be 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
Tidsram: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in skin conductance level will be 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
Tidsram: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
Changes in respiration rate will be measured.
2 min baseline before the trauma movie and during 15 min of the trauma movie.
Salivary oxytocin concentrations
Tidsram: 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.
Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Salivary cortisol concentrations
Tidsram: 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.
Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
Questionnaire measurement of mood (PANAS)
Tidsram: 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.
10 min before and 10 min after the trauma movie.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Bonn

Utredare

  • Huvudutredare: René Hurlemann, MD, PhD, University of Bonn

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2016

Primärt slutförande (Faktisk)

18 mars 2017

Avslutad studie (Faktisk)

18 mars 2017

Studieregistreringsdatum

Först inskickad

28 januari 2018

Först inskickad som uppfyllde QC-kriterierna

1 februari 2018

Första postat (Faktisk)

8 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 februari 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 februari 2018

Senast verifierad

1 februari 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PROXY

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

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Nej

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