Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425929
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2018-01-28
Brief Title:
Oxytocin Trauma Disclosure and Intrusions
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie one measurement before the treatment and one measurement after three days of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None