NCT01039766

The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)

The Efficacy of the Proximate Administration of Oxytocin After a Traumatic Event in Preventing the Development of Post Traumatic Stress Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 67 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to test the hypothesis that a single administration of intranasal oxytocin within 6 hours post-trauma facilitates the physiological recovery for the trauma, thereby preventing the development of Post Traumatic Stress Disorder (PTSD) in the months following the event. In the absence of such treatment (i.e., under placebo conditions), we hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover from acute effects).

Detailed description

This is a double-blind, placebo-controlled trial in which trauma victims are randomized to receive a single intranasal administration of either Oxytocin (40IU) or placebo within the first six hours following trauma exposure. To provide a pre-treatment baseline, participants will receive a medical and psychological evaluation prior to treatment. After two weeks the research assistant or study psychiatrist will perform behavioral ratings and complete history details pertaining to PTSD risk factors. Participants will be assessed again by the study psychiatrist or research assistants at 1, 3, 6 and 13 months. Eligible subjects will include men and women over the age of 18, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, and who provide written, informed consent to participate in the study. In order to recruit persons who are more likely to be at risk for the development of PTSD, we will only randomize persons expressing marked anxiety, emotional distress or dissociation, as assessed by the Visual Analog Scales. Potential participants will be recruited from trauma victims arriving at the Chaim Sheba Medical Center Emergency Room.

Conditions

• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Oxytocin	A single intranasal administration of 40 IU of oxytocin will be given to patients up to 6 hours after a traumatic event, with consecutive follow up for 13 months.
DRUG	placebo - saline nasal spray	A single intranasal administration of saline will be given to patients up to 6 hours after a traumatic event, with consecutive follow up for 13 months as the control to the oxytocin arm

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-01-01
• Completion: 2011-06-01
• First posted: 2009-12-25
• Last updated: 2010-02-09

Locations

1 site across 1 country: Israel