Stress Disorders, Post-TraumaticNCT01039766
The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)
A study testing Oxytocin in people with Stress Disorders, Post-Traumatic, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Joseph Zohar, MD, 972-3-5303300, jzohar@post.tau.ac.il
Shlomit Cwikel-Hamzany, MD, 972-52-4746120, shlomitch@gmail.com
About this study
Official title: 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).
Read the 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
- Being tested
- Oxytocin, placebo - saline nasal spray
- Keywords
- post traumatic stress disorder, prevention, oxytocin
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon nasal spray
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.
placebo - saline nasal sprayDrug
Also called saline nasal spray prepared by the hospital's pharmacy
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
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Not described Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo - saline nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.
Measured: 13 months
Secondary outcomes (1)
The secondary outcome measure is the severity of PTSD as expressed by the Clinician Administered PTSD Scale (CAPS), at the end of the trial.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (70)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Alzbeta Juven Wetzler, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039766
- Sponsor's protocol ID
- SHEBA-09-7128-AJW-CTIL
- Status last verified
- Feb 2010
- First submitted
- 23 Dec 2009
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Andrews B, Brewin CR, Rose S, Kirk M. Predicting PTSD symptoms in victims of violent crime: the role of shame, anger, and childhood abuse. J Abnorm Psychol. 2000 Feb;109(1):69-73. doi: 10.1037//0021-843x.109.1.69.
PubMed 10740937Beckner VE, Tucker DM, Delville Y, Mohr DC. Stress facilitates consolidation of verbal memory for a film but does not affect retrieval. Behav Neurosci. 2006 Jun;120(3):518-27. doi: 10.1037/0735-7044.120.3.518.
PubMed 16768603Davidson JR, Tupler LA, Wilson WH, Connor KM. A family study of chronic post-traumatic stress disorder following rape trauma. J Psychiatr Res. 1998 Sep-Oct;32(5):301-9. doi: 10.1016/S0022-3956(98)00016-8.
PubMed 9789209Koenen KC, Harley R, Lyons MJ, Wolfe J, Simpson JC, Goldberg J, Eisen SA, Tsuang M. A twin registry study of familial and individual risk factors for trauma exposure and posttraumatic stress disorder. J Nerv Ment Dis. 2002 Apr;190(4):209-18. doi: 10.1097/00005053-200204000-00001.
PubMed 11960081Kuhlmann S, Wolf OT. Arousal and cortisol interact in modulating memory consolidation in healthy young men. Behav Neurosci. 2006 Feb;120(1):217-23. doi: 10.1037/0735-7044.120.1.217.
PubMed 16492134Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
PubMed 17466428Stein MB, Jang KL, Taylor S, Vernon PA, Livesley WJ. Genetic and environmental influences on trauma exposure and posttraumatic stress disorder symptoms: a twin study. Am J Psychiatry. 2002 Oct;159(10):1675-81. doi: 10.1176/appi.ajp.159.10.1675.
PubMed 12359672Yehuda R, Bierer LM, Schmeidler J, Aferiat DH, Breslau I, Dolan S. Low cortisol and risk for PTSD in adult offspring of holocaust survivors. Am J Psychiatry. 2000 Aug;157(8):1252-9. doi: 10.1176/appi.ajp.157.8.1252.
PubMed 10910787Yehuda R, Halligan SL, Bierer LM. Relationship of parental trauma exposure and PTSD to PTSD, depressive and anxiety disorders in offspring. J Psychiatr Res. 2001 Sep-Oct;35(5):261-70. doi: 10.1016/s0022-3956(01)00032-2.
PubMed 11591428Yehuda R, Halligan SL, Grossman R. Childhood trauma and risk for PTSD: relationship to intergenerational effects of trauma, parental PTSD, and cortisol excretion. Dev Psychopathol. 2001 Summer;13(3):733-53. doi: 10.1017/s0954579401003170.
PubMed 11523857Yehuda R, Harvey PD, Buchsbaum M, Tischler L, Schmeidler J. Enhanced effects of cortisol administration on episodic and working memory in aging veterans with PTSD. Neuropsychopharmacology. 2007 Dec;32(12):2581-91. doi: 10.1038/sj.npp.1301380. Epub 2007 Mar 28.
PubMed 17392739Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. doi: 10.1056/NEJMra012941. No abstract available.
PubMed 11784878Anisman H, Griffiths J, Matheson K, Ravindran AV, Merali Z. Posttraumatic stress symptoms and salivary cortisol levels. Am J Psychiatry. 2001 Sep;158(9):1509-11. doi: 10.1176/appi.ajp.158.9.1509.
PubMed 11532740Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7. doi: 10.1016/s0006-3223(00)00896-9.
PubMed 11074232Delahanty DL, Raimonde AJ, Spoonster E, Cullado M. Injury severity, prior trauma history, urinary cortisol levels, and acute PTSD in motor vehicle accident victims. J Anxiety Disord. 2003;17(2):149-64. doi: 10.1016/s0887-6185(02)00185-8.
PubMed 12614659
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Proximate Administration of Oxytocin After a Traumatic Event in Preventing the Development of Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01039766
- Acronym / sponsor ID
- SHEBA-09-7128-AJW-CTIL
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- post traumatic stress disorder, prevention, oxytocin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: Oxytocin |
| Placebo | Placebo comparator | Drug: placebo - saline nasal spray |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: syntocinon nasal sprayA 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 | oxytocin |
| placebo - saline nasal sprayAlso: saline nasal spray prepared by the hospital's pharmacyA 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 | Drug | Placebo |
Primary outcome
The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial.
Time frame: 13 months
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2010.
- Background: PubMed 10740937Andrews B, Brewin CR, Rose S, Kirk M. Predicting PTSD symptoms in victims of violent crime: the role of shame, anger, and childhood abuse. J Abnorm Psychol. 2000 Feb;109(1):69-73. doi: 10.1037//0021-843x.109.1.69.
- Background: PubMed 16768603Beckner VE, Tucker DM, Delville Y, Mohr DC. Stress facilitates consolidation of verbal memory for a film but does not affect retrieval. Behav Neurosci. 2006 Jun;120(3):518-27. doi: 10.1037/0735-7044.120.3.518.
- Background: PubMed 9789209Davidson JR, Tupler LA, Wilson WH, Connor KM. A family study of chronic post-traumatic stress disorder following rape trauma. J Psychiatr Res. 1998 Sep-Oct;32(5):301-9. doi: 10.1016/S0022-3956(98)00016-8.
- Background: PubMed 11960081Koenen KC, Harley R, Lyons MJ, Wolfe J, Simpson JC, Goldberg J, Eisen SA, Tsuang M. A twin registry study of familial and individual risk factors for trauma exposure and posttraumatic stress disorder. J Nerv Ment Dis. 2002 Apr;190(4):209-18. doi: 10.1097/00005053-200204000-00001.
- Background: PubMed 16492134Kuhlmann S, Wolf OT. Arousal and cortisol interact in modulating memory consolidation in healthy young men. Behav Neurosci. 2006 Feb;120(1):217-23. doi: 10.1037/0735-7044.120.1.217.
- Background: PubMed 17466428Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
- Background: PubMed 12359672Stein MB, Jang KL, Taylor S, Vernon PA, Livesley WJ. Genetic and environmental influences on trauma exposure and posttraumatic stress disorder symptoms: a twin study. Am J Psychiatry. 2002 Oct;159(10):1675-81. doi: 10.1176/appi.ajp.159.10.1675.
- Background: PubMed 10910787Yehuda R, Bierer LM, Schmeidler J, Aferiat DH, Breslau I, Dolan S. Low cortisol and risk for PTSD in adult offspring of holocaust survivors. Am J Psychiatry. 2000 Aug;157(8):1252-9. doi: 10.1176/appi.ajp.157.8.1252.
- Background: PubMed 11591428Yehuda R, Halligan SL, Bierer LM. Relationship of parental trauma exposure and PTSD to PTSD, depressive and anxiety disorders in offspring. J Psychiatr Res. 2001 Sep-Oct;35(5):261-70. doi: 10.1016/s0022-3956(01)00032-2.
- Background: PubMed 11523857Yehuda R, Halligan SL, Grossman R. Childhood trauma and risk for PTSD: relationship to intergenerational effects of trauma, parental PTSD, and cortisol excretion. Dev Psychopathol. 2001 Summer;13(3):733-53. doi: 10.1017/s0954579401003170.
- Background: PubMed 17392739Yehuda R, Harvey PD, Buchsbaum M, Tischler L, Schmeidler J. Enhanced effects of cortisol administration on episodic and working memory in aging veterans with PTSD. Neuropsychopharmacology. 2007 Dec;32(12):2581-91. doi: 10.1038/sj.npp.1301380. Epub 2007 Mar 28.
- Background: PubMed 11784878Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. doi: 10.1056/NEJMra012941. No abstract available.
Related trials for Stress Disorders, Post-Traumatic
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alzbeta Juven Wetzler, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in people with Stress Disorders, Post-Traumatic, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Zohar, MD (972-3-5303300, jzohar@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial. (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039766, which also lists 70 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2010.