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

Primary Purpose

PTSD

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oxytoine
PLACEBO
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Oxytocin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    intervention

    Placebo treatments

    Arm Description

    intervention: Oxytoine treatments - 20 PTSD patients

    Other: Placebo treatments- 20 PTSD patients

    Outcomes

    Primary Outcome Measures

    Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 8, 2015
    Last Updated
    January 12, 2015
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02336568
    Brief Title
    The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PTSD
    Keywords
    PTSD, Oxytocin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention
    Arm Type
    Experimental
    Arm Description
    intervention: Oxytoine treatments - 20 PTSD patients
    Arm Title
    Placebo treatments
    Arm Type
    Placebo Comparator
    Arm Description
    Other: Placebo treatments- 20 PTSD patients
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytoine
    Other Intervention Name(s)
    syntocinon nasal spray nasal
    Intervention Description
    In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
    Intervention Type
    Drug
    Intervention Name(s)
    PLACEBO
    Intervention Description
    In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ehud Klein, Prof.
    Phone
    972-4-7772559
    Email
    e_klein@rambam.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sharon Palgi, Ph.D.
    Phone
    972-4-7773032
    Email
    s_palgi@rambam.health.gov.il

    12. IPD Sharing Statement

    Learn more about this trial

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

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