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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: syntocinon nasal spray
* Drug: placebo nasal spray


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>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<br>* nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)<br>* Other names: nasal oxytocin - 24 IU,;Drug: placebo nasal spray<br>* nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)<br>* Other names: nasal placebo - 24 IU,;|
| Other: control group<br>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<br>* nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)<br>* Other names: nasal oxytocin - 24 IU,;Drug: placebo nasal spray<br>* nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)<br>* Other names: nasal placebo - 24 IU,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)). | 1 hour after the inhalation the OT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, empathy, oxytocin