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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02336568
• Other study ID #: 370-14CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 8, 2015
• Last updated: January 12, 2015
• Start date: March 2015
• Est. completion date: March 2018

Study information

• Verified date: January 2015
• Source: Rambam Health Care Campus
• Contact: Ehud Klein, Prof.
• Phone: 972-4-7772559
• Email: e_klein[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Oxytoine
In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
• PLACEBO
In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No