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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01039766
First received: December 23, 2009
Last updated: February 7, 2010
Last verified: February 2010
  Purpose

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).


Condition Intervention
Stress Disorders, Post-Traumatic
Drug: Oxytocin
Drug: placebo - saline nasal spray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of the Proximate Administration of Oxytocin After a Traumatic Event in Preventing the Development of Post Traumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: syntocinon nasal spray
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 Name: saline nasal spray prepared by the hospital's pharmacy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039766

Contacts
Contact: Joseph Zohar, MD 972-3-5303300 jzohar@post.tau.ac.il
Contact: Shlomit Cwikel-Hamzany, MD 972-52-4746120 shlomitch@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Ramat-Gan, Israel
Contact: Joseph Zohar, MD    972-3-5303300    jzohar@post.tau.ac.il   
Contact: Shlomit Cwikel-Hamzany, MD    972-52-4746120    shlomitch@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Alzbeta Juven Wetzler, MD Sheba Medical Center
  More Information

Publications:

Responsible Party: Prof. Joseph Zohar, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01039766     History of Changes
Other Study ID Numbers: SHEBA-09-7128-AJW-CTIL
Study First Received: December 23, 2009
Last Updated: February 7, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
post traumatic stress disorder
prevention
oxytocin

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014