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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-03-31

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.

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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.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intervention

intervention: Oxytoine treatments - 20 PTSD patients

Group Type EXPERIMENTAL

Oxytoine

Intervention Type DRUG

In the first week 24 IU \* 2/day. in the 2nd \& 3rd 40 IU \* 2/day

Placebo treatments

Other: Placebo treatments- 20 PTSD patients

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DRUG

In the first week 24 IU \* 2/day. in the 2nd \& 3rd 40 IU \* 2/day

Interventions

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Oxytoine

In the first week 24 IU \* 2/day. in the 2nd \& 3rd 40 IU \* 2/day

Intervention Type DRUG

PLACEBO

In the first week 24 IU \* 2/day. in the 2nd \& 3rd 40 IU \* 2/day

Intervention Type DRUG

Other Intervention Names

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syntocinon nasal spray nasal

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No