The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)

PTSD Clinical Trial

Official title: The Effect of 21-Days Intranasal Oxytocin on Clinical Symptoms and Social Function in Patients With Post Traumatic Stress Disorder (PTSD), a Randomized Controled Trail

Status Not yet recruiting

Clinical Trial Summary

Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a mediator stress regulation and improves social bonding. 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. In two current studies that were conducted in Rambam health care we found that a single dose of intranasal OT reduces anxiety and irritability symptoms, and enhances emotional empathy and compassion, in patients with PTSD. The main goal of this study is to examine the effects of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients.

Clinical Trial Description

This study will examine the effect is of 21-days intranasal Oxytocin on clinical symptoms and social function in these patients, in a double blind (treatment/placebo) study design. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT02336568
• Study type: Interventional
• Source: Rambam Health Care Campus
• Contact: Ehud Klein, Prof.
• Phone: 972-4-7772559
• Email: e_klein@rambam.health.gov.il
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2015
• Completion date: March 2018