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

NCT02336568 | Unknown Phase 4

• 1 other identifier: 370-14CTIL
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD

Keywords

PTSD, Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intervention

EXPERIMENTAL

intervention: Oxytoine treatments - 20 PTSD patients

Drug: Oxytoine

Placebo treatments

PLACEBO COMPARATOR

Other: Placebo treatments- 20 PTSD patients

Drug: PLACEBO

Interventions

Oxytoine DRUG

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

Also known as: syntocinon nasal spray nasal

intervention

PLACEBO DRUG

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

Placebo treatments

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD patients (DSM-IV criteria)
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Ehud Klein, Prof.

CONTACT

972-4-7772559; e_klein@rambam.health.gov.il

Sharon Palgi, Ph.D.

CONTACT

972-4-7773032; s_palgi@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2018
• Last Updated: January 13, 2015

Record last verified: 2015-01