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

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oxytocin
placebo - saline nasal spray
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Post-Traumatic focused on measuring post traumatic stress disorder, prevention, oxytocin

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

oxytocin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.

Secondary Outcome Measures

The secondary outcome measure is the severity of PTSD as expressed by the Clinician Administered PTSD Scale (CAPS), at the end of the trial.

Full Information

First Posted
December 23, 2009
Last Updated
February 7, 2010
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01039766
Brief Title
The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)
Official Title
The Efficacy of the Proximate Administration of Oxytocin After a Traumatic Event in Preventing the Development of Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
post traumatic stress disorder, prevention, oxytocin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
syntocinon nasal spray
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo - saline nasal spray
Other Intervention Name(s)
saline nasal spray prepared by the hospital's pharmacy
Intervention Description
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
Primary Outcome Measure Information:
Title
The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.
Time Frame
13 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 The traumatic event occured up to six hour prior to the arrival to the emergency room The person can and is willing to provide written, informed consent to participate in the study. Exclusion Criteria: 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; Head injury involving confusion, loss of consciousness, or amnesia; Medical conditions in which oxytocin administration might cause harm to the patient such as patients with a cardiovascular disease or intracranial mass. Weight below 45 or above 100 kg. Pregnancy (in suggestive cases, a pregnancy test will be performed); Traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. Overt psychopathology, intoxication, or under the influence of substances. Evidence or history of schizophrenia, bipolar, other psychotic condition, autism; Prior history of PTSD; Current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; Assessed serious suicide risk.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Zohar, MD
Phone
972-3-5303300
Email
jzohar@post.tau.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomit Cwikel-Hamzany, MD
Phone
972-52-4746120
Email
shlomitch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alzbeta Juven Wetzler, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, MD
Phone
972-3-5303300
Email
jzohar@post.tau.ac.il
First Name & Middle Initial & Last Name & Degree
Shlomit Cwikel-Hamzany, MD
Phone
972-52-4746120
Email
shlomitch@gmail.com

12. IPD Sharing Statement

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

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