Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related symptoms.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 124

Inclusion Criteria

* Presentation at the Trauma Room or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV (either as a patient or direct witness);
* Trauma Screening Questionnaire (TSQ) <=/> 5 and/or Peritraumatic Distress Inventory (PDI ) <=/> 17 preferably between 24 and 72 hours after trauma exposure (in case of contacting difficulties up to 7 days after trauma);
* Age 18 * 65 years;
* Capable to read and comprehend either the Dutch or English language;

Exclusion Criteria

* Any severe or chronic systemic disease;
* Current psychotic, bipolar, substance-related, severe personality disorder, or mental retardation;
* Current severe depressive disorder;
* Prominent current suicidal risk or homicidal ideation;
* Severe cognitive impairment or a history of organic mental disorder;
* Evidence of PTSD or depression immediately prior to the index trauma;
* History of neurological disorders (e.g., traumatic brain injury, seizure history;
* Reports of ongoing traumatization (e.g., in case of partner violence as index adult trauma;
* Evidence of clinically significant and unstable medical conditions in which OT administration is contra-indicative such as cardiovascular, gastro-intestinal, pulmonary, severe renal, endocrine or hematological disorders, glaucoma, history of epilepsy, or a stroke or myocardial infarction within the past year;
* Use of certain medication: prostaglandins, certain anti-migraine medications (ergot alkaloids), bèta-adrenergic receptor-blocking agents, and systemic glucocorticoids;
* Sensitivity or allergy for OT or its components (e.g., methylhydroxybenzoate and propylhydroxybenzoate);
* Impaired consciousness, or amnesia or confusion (due to for example head injury) (objectified by Glasgow Coma Scale lower than 13 at time of inclusion)
* Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome is the difference in PTSD symptoms severity (CAPS<br /><br>scores) between the two trial arms (i.e. OT versus placebo) at one month post<br /><br>intervention follow-up.<br /><br><br /><br>The main study outcomes for the fMRI substudy are differences in amygdala<br /><br>activation to emotional faces and differences in brain functional connectivity<br /><br>after stress induction between the two study conditions.</p><br>

Secondary Outcome Measures