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

Rambam Health Care Campus

Status and phase: Unknown; Phase 4

Conditions: PTSD

Treatments: Drug: PLACEBO; Drug: Oxytoine

Study type: Interventional

Funder types: Other

Identifiers

NCT02336568

370-14CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

intervention

Experimental group

Description:

intervention: Oxytoine treatments - 20 PTSD patients

Treatment:

Drug: Oxytoine

Placebo treatments

Placebo Comparator group

Description:

Other: Placebo treatments- 20 PTSD patients

Treatment:

Drug: PLACEBO