Oxytocine en social support after a traumatic event
- Conditions
- Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IVMedDRA version: 14.0Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-004177-83-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
?Presentation at the Trauma Unit or Emergency Department after a potential traumatic event, according to PTSD A1 criterion in the DSM-IV
?Trauma Screening Questionnaire (TSQ) > 5 between 24 and 72 hours after trauma exposure
?Age 18 – 65 years
?Significant other (i.e. best friend, partner or family member) willing to join the social support intervention
?Capable to read and comprehend either the Dutch or English language
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
?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 prostaglandins and certain anti-migraine medications (ergot alkaloids)
?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) (Glasgow Coma Scale lower than 13)
?Female participants: pregnancy and breast feeding (NB. Female participants with childbearing potential must have a negative pregnancy test).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method