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Oxytocine en social support after a traumatic event

Conditions
Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV
MedDRA version: 14.0Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic 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
Inclusion Criteria

?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

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 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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