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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02336568

Enrollment

Registered

2015-01-13

Start date

2015-03-31

Completion date

2018-03-31

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

PTSD, Oxytocin

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.

Interventions

DRUGOxytoine

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

DRUGPLACEBO

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

Contacts

Primary ContactEhud Klein, Prof.

e_klein@rambam.health.gov.il972-4-7772559

Backup ContactSharon Palgi, Ph.D.

s_palgi@rambam.health.gov.il972-4-7773032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026