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

Phase 4

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: syntocinon nasal spray; Drug: placebo nasal spray

• Registration Number: NCT01325168
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-20
• Study First Submitted QC: 2011-03-27
• Study First Posted: 2011-03-29
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2013-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
study group	syntocinon nasal spray	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	placebo nasal spray	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)
control group	syntocinon nasal spray	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)
study group	placebo nasal spray	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)

Primary Outcome Measures

Name	Time	Method
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.	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)).

Trial Locations

Locations (2)

Rambam Medical Center; 🇮🇱 Haifa, Israel

Rambam health care campus; 🇮🇱 Haifa, Israel