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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01325168
Enrollment
62
Registered
2011-03-29
Start date
2011-08-31
Completion date
2013-04-30
Last updated
2015-05-07

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

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD, empathy, oxytocin

Brief summary

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.

Interventions

DRUGsyntocinon nasal spray

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

DRUGplacebo nasal spray

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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.1 hour after the inhalation the OTThe 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)).

Countries

Israel

Outcome results

None listed

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