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

Rambam Health Care Campus

Status and phase: Completed; Phase 4

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: placebo nasal spray; Drug: syntocinon nasal spray

Study type: Interventional

Funder types: Other

Identifiers

NCT01325168

0085-11CTIL

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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62 participants in 2 patient groups

study group

Experimental group

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)

Treatment:

Drug: syntocinon nasal spray

Drug: placebo nasal spray

control group

Other group

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)

Treatment:

Drug: syntocinon nasal spray

Drug: placebo nasal spray