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

February 7, 2010 updated by: Sheba Medical Center

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat-Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Persons over the age of 18, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, expressing marked anxiety, and/ or emotional distress and/or dissociation, as assessed by the Visual Analog Scales
  2. The traumatic event occured up to six hour prior to the arrival to the emergency room
  3. The person can and is willing to provide written, informed consent to participate in the study.

Exclusion Criteria:

  1. Physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. Examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by Abbreviated Injury Scale (AIS), or by clinical judgment;
  2. Head injury involving confusion, loss of consciousness, or amnesia;
  3. Medical conditions in which oxytocin administration might cause harm to the patient such as patients with a cardiovascular disease or intracranial mass.
  4. Weight below 45 or above 100 kg.
  5. Pregnancy (in suggestive cases, a pregnancy test will be performed);
  6. Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.
  7. Overt psychopathology, intoxication, or under the influence of substances.
  8. Evidence or history of schizophrenia, bipolar, other psychotic condition, autism;
  9. Prior history of PTSD;
  10. Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure;
  11. Assessed serious suicide risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
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
Other Names:
  • saline nasal spray prepared by the hospital's pharmacy
EXPERIMENTAL: oxytocin
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.
Other Names:
  • syntocinon nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.
Time Frame: 13 months
13 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measure is the severity of PTSD as expressed by the Clinician Administered PTSD Scale (CAPS), at the end of the trial.
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Alzbeta Juven Wetzler, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

June 1, 2011

Study Registration Dates

First Submitted

December 23, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (ESTIMATE)

December 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2010

Last Update Submitted That Met QC Criteria

February 7, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-7128-AJW-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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