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The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01325168
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. Recently, several theoretical studies suggested that PTSD patients have abnormal functioning of the OT system. According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: syntocinon nasal spray Drug: placebo nasal spray Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: study group
32 PTSD patients intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Drug: syntocinon nasal spray
nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Other Name: nasal oxytocin - 24 IU,

Drug: placebo nasal spray
nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Other Name: nasal placebo - 24 IU,

control group
control group - 30 healthy control subjects intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Drug: syntocinon nasal spray
nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Other Name: nasal oxytocin - 24 IU,

Drug: placebo nasal spray
nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Other Name: nasal placebo - 24 IU,




Primary Outcome Measures :
  1. Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients. [ Time Frame: 1 hour after the inhalation the OT ]
    The computer tasks will assess emotional empathy(e.g. task that assess the ability to recognizes emotional facial expressions ('face morphing'), and task that assess the ability to recognizes emotions depicted in a biological motion ('biological motion')), And cognitive empathy ( task that assess the ability to judge mental states based on verbal and eye gaze cues (ToM task)).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PTSD patients (DSM-IV criteria)
  • Ability to provide written informed consent

Exclusion Criteria:

  • Suicidality
  • Psychosis
  • Arrhythmia
  • Cardiac disease (arrythmia, heart failure)
  • Hyponatremia
  • Severe renal insufficiency
  • Liver cirrhosis
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325168


Locations
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Israel
Rambam health care campus
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Ehud Klein, MD. Rambam Health Care Campus
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01325168    
Other Study ID Numbers: 0085-11CTIL
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: May 7, 2015
Last Verified: May 2015
Keywords provided by Rambam Health Care Campus:
PTSD
empathy
oxytocin
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs