NL-OMON39401CompletedPhase 2
Boosting Oxytocin after trauma: Neurobiology and the Development of Stress-related symptoms. - BONDS
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 124
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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);
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