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Completed

NCT Number: NCT01325168

The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)

Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy. 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. The main goal of this study is to examine the effects of administration of nasal OT on empathic abilities among PTSD patients. Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rambam Medical Center, Haifa, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Suicidality
  • Psychosis
  • Arrhythmia
  • Cardiac disease (arrythmia, heart failure)
  • Hyponatremia
  • Severe renal insufficiency
  • Liver cirrhosis
  • Pregnancy

Treatment and study plan

syntocinon nasal spray

Drug

nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)

Other names: nasal oxytocin - 24 IU,

Placebo nasal spray

Drug

nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)

Other names: nasal placebo - 24 IU,

Primary outcomes

  1. Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients.

    Time frame: 1 hour after the inhalation the OT

    The computer tasks will assess emotional empathy(e.g. task that assess the ability to recognizes emotional facial expressions ('face morphing'), and task that assess the ability to recognizes emotions depicted in a biological motion ('biological motion')), And cognitive empathy ( task that assess the ability to judge mental states based on verbal and eye gaze cues (ToM task)).

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With PTSD

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 29, 2011
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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