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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
syntocinon nasal spray
placebo nasal spray
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, empathy, oxytocin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rambam health care campus
  • Rambam Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

study group

control group

Arm Description

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)

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)

Outcomes

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.
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)).

Secondary Outcome Measures

Full Information

First Posted
March 20, 2011
Last Updated
May 6, 2015
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT01325168
Brief Title
The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)
Official Title
The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD, empathy, oxytocin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
Other
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
syntocinon nasal spray
Other Intervention Name(s)
nasal oxytocin - 24 IU,
Intervention Description
nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Intervention Type
Drug
Intervention Name(s)
placebo nasal spray
Other Intervention Name(s)
nasal placebo - 24 IU,
Intervention Description
nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
Primary Outcome Measure Information:
Title
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.
Description
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)).
Time Frame
1 hour after the inhalation the OT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehud Klein, MD.
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel

12. IPD Sharing Statement

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

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