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

This study is not yet open for participant recruitment.
Verified February 2011 by Rambam Health Care Campus
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01325168
First received: March 20, 2011
Last updated: March 27, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Post Traumatic Stress Disorder
 Drug: syntocinon nasal spray
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD

Resource links provided by NLM:

Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)).


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study group
30 PTSD patients
 Drug: syntocinon nasal spray
nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
control group
control group - 30 healthy control subjects
 Drug: syntocinon nasal spray
nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325168

Contacts
Contact: Ehud Klein, MD 972-4-8542559 e_klein@rambam.health.gov.il
Contact: Simon Shamay-Tsoory, PhD. 972-4-8288778 sshamay@psy.haifa.ac.il

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Ehud Klein, MD.     972-4-8542559     e_klein@rambam.health.gov.il    
Contact: Sharon Haviv-Palgi, M.A.     972-4-8543032     s_palgi@rambam.health.gov.il    
Principal Investigator: Ehud Klein, MD.            
Principal Investigator: Simon Shamay-Tsoory, PhD.            
Sub-Investigator: Sharon Haviv-Palgi, M.A.            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ehud Klein, MD. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Ehud Klein, MD. Head Department of Psychiatry, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT01325168     History of Changes
Other Study ID Numbers: 0085-11CTIL
Study First Received: March 20, 2011
Last Updated: March 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
PTSD
empathy
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 May 19, 2013