NCT01325168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

March 20, 2011

Last Update Submit

May 6, 2015

Conditions

Post Traumatic Stress Disorder

Keywords

PTSDempathyoxytocin

Outcome Measures

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.

    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)).

    1 hour after the inhalation the OT

Study Arms (2)

study group

EXPERIMENTAL

32 PTSD patients intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)

Drug: syntocinon nasal sprayDrug: placebo nasal spray

control group

OTHER

control group - 30 healthy control subjects intervention: Drug: syntocinon nasal spray / placebo nasal spray nasal OT - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)

Drug: syntocinon nasal sprayDrug: placebo nasal spray

Interventions

syntocinon nasal sprayDRUG

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

Also known as: nasal oxytocin - 24 IU,
control groupstudy group
placebo nasal sprayDRUG

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

Also known as: nasal placebo - 24 IU,
control groupstudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • Arrhythmia
  • Cardiac disease (arrythmia, heart failure)
  • Hyponatremia
  • Severe renal insufficiency
  • Liver cirrhosis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rambam health care campus

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Ehud Klein, MD.

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2011

First Posted

March 29, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

April 1, 2013

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

IL(2)