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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02336568
Recruitment Status : Unknown
Verified January 2015 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
PTSD Drug: Oxytoine Drug: PLACEBO Phase 4

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention
intervention: Oxytoine treatments - 20 PTSD patients
 Drug: Oxytoine
In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
Other Name: syntocinon nasal spray nasal
Placebo Comparator: Placebo treatments
Other: Placebo treatments- 20 PTSD patients
 Drug: PLACEBO
In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day


Outcome Measures
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Primary Outcome Measures :
  1. Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior) [ Time Frame: 3 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336568


Contacts
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Contact: Ehud Klein, Prof. 972-4-7772559 e_klein@rambam.health.gov.il
Contact: Sharon Palgi, Ph.D. 972-4-7773032 s_palgi@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
More Information
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02336568    
Other Study ID Numbers: 370-14CTIL
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015
Keywords provided by Rambam Health Care Campus:
PTSD, Oxytocin
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
 Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs