The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD
Overview
- Phase
- Phase 4
- Intervention
- syntocinon nasal spray
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
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)
Intervention: syntocinon nasal spray
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)
Intervention: placebo nasal spray
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)
Intervention: syntocinon nasal spray
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)
Intervention: placebo nasal spray
Outcomes
Primary Outcomes
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)).