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
Overview
- Phase
- Phase 4
- Intervention
- PLACEBO
- Conditions
- PTSD
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 40
- Primary Endpoint
- Semi-structured interviews (CAPS)and self-report questionnaires that examine the symptoms of the disorder and related symptoms (social function and aggressive behavior)
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
Placebo treatments
Other: Placebo treatments- 20 PTSD patients
Intervention: PLACEBO
intervention
intervention: Oxytoine treatments - 20 PTSD patients
Intervention: Oxytoine
Outcomes
Primary Outcomes
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