The Effect of 21-Days Intranasal Oxytocin on Patients With Post Traumatic Stress Disorder (PTSD)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
PTSD | Drug: Oxytoine Drug: PLACEBO | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: intervention
intervention: Oxytoine treatments - 20 PTSD patients
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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
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Drug: PLACEBO
In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day |
- 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 ]

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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 |
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

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
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 |
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 |
PTSD, Oxytocin |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |
Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |