NL-OMON39401
Completed
Phase 2
Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related symptoms. - BONDS
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- posttraumatic stress disorder (PTSD) and stress disorder
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 124
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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