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

NCT01039766 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2010-02-09

No results posted yet for this study

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).

Conditions

  • Stress Disorders, Post-Traumatic

Interventions

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

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Alzbeta Juven Wetzler, MD · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01039766 on ClinicalTrials.gov