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Clinical Trials/EUCTR2011-004177-83-NL
EUCTR2011-004177-83-NL
Active, not recruiting
Not Applicable

Boosting the oxytocin system in acute trauma: The effectiveness of intranasal oxytocin treatments and stimulation of social support on preventing trauma related psychopathology - Oxytocin and social support as early interventions in acute trauma

Academic Medical Center0 sitesSeptember 7, 2011
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ConditionsPosttraumatic 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]
DrugsSyntocinon, nasal spray 40 IU/ml

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder (PTSD) according to criteria in the DSM-IV
Sponsor
Academic Medical Center
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 7, 2011
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Academic Medical Center

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Not specified

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