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

Phase 4

• Conditions: PTSD
• Interventions: Drug: PLACEBO; Drug: Oxytoine

• Registration Number: NCT02336568
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed 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 Timeline

• Status Verified: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Last Update Submitted: 2015-01-12
• Study First Posted: 2015-01-13
• Last Update Posted: 2015-01-13
• Study Start: 2015-03
• Primary Completion: 2016-12
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• PTSD patients (DSM-IV criteria)
• Ability to provide written informed consent

Exclusion Criteria

• Suicidality
• Psychosis
• Borderline Personality
• Arrhythmia
• Cardiac disease (arrythmia, heart failure)
• Hyponatremia
• Hypertension
• Severe renal insufficiency
• Liver cirrhosis
• Lactating or pregnant women, or undergoing fertility treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo treatments	PLACEBO	Other: Placebo treatments- 20 PTSD patients
intervention	Oxytoine	intervention: Oxytoine treatments - 20 PTSD patients

Primary Outcome Measures

Name	Time	Method
Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)	3 weeks