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

NCT02336568 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-01-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Oxytoine

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

DRUG

PLACEBO

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

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2018-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02336568 on ClinicalTrials.gov