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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PTSD

Intervention / Treatment
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* Drug: Oxytoine
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>intervention: Oxytoine treatments - 20 PTSD patients | Drug: Oxytoine<br>* In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day<br>* Other names: syntocinon nasal spray nasal;|
| Placebo Comparator: Placebo treatments<br>Other: Placebo treatments- 20 PTSD patients | Drug: PLACEBO<br>* In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Oxytocin