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The Effect of Intranasal Administration of Oxytocin on Empathic Abilities. (20070766)

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Oxytocin (also: syntocinon, pitocin)
Placebo
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring ToM, Theory of Mind, Simulation, Empathy, Oxytocin, Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (for schizophrenic patients):

  1. Range of age between 18 and 45 years.
  2. The patient is diagnosed as suffering from schizophrenia by 2 independent psychiatrists, according to DSM-IV criteria.
  3. The participant is able to commit to 2 trials with 7 days interval.
  4. The participant has been informed orally and in writing and has given his/her written consent.
  5. When necessary, a psychiatrist has determined the patient's ability to agree, orally and in writing.

Inclusion Criteria (for healthy patients):

  1. Range of age between 18 and 45 years.
  2. The participant is able to commit to 2 trials with 7 days interval.
  3. The participant has been informed orally and in writing and Has given his/her written consent.

Exclusion Criteria (for schizophrenic patients):

  1. The participant is suffering from other acute, unstable, significant or untreated medical Illness, including arrhythmia and head injury.
  2. The participant is suffers from an axis II disorder of DSM-IV.
  3. The participant has history of alcohol or drug abuse.
  4. The participant is pregnant or breast-feeding.
  5. The participant suffers from mental retardation (IQ less than 75).
  6. The participant has any disturbance in visuomotor coordination.
  7. The participant has smoked a cigarette in the day of the trial.
  8. High suicidal risk, as determined by the treating physician.

Exclusion Criteria (for healthy patients):

  1. The participant is suffering from acute, unstable, significant or untreated medical Illness, including arrhythmia and head injury.
  2. The participant has history of alcohol or drug abuse.
  3. The participant is pregnant or breast-feeding.
  4. The participant suffers from mental retardation (IQ less than 75).
  5. The participant has any disturbance in visuomotor coordination.
  6. The participant has smoked a cigarette in the day of the trial.

Sites / Locations

  • Shalvata Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Oxytocin

Placebo

Outcomes

Primary Outcome Measures

accuracy level (in percentage) and reaction time (in milliseconds) of emotional facial expressions recognition in a dynamic emotional facial expressions task.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2008
Last Updated
February 4, 2009
Sponsor
Shalvata Mental Health Center
Collaborators
University of Haifa
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1. Study Identification

Unique Protocol Identification Number
NCT00813436
Brief Title
The Effect of Intranasal Administration of Oxytocin on Empathic Abilities.
Acronym
20070766
Official Title
The Effect of Intranasal Administration of Oxytocin on Empathic Abilities of Healthy People and People Who Suffer From Schizophrenia.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shalvata Mental Health Center
Collaborators
University of Haifa

4. Oversight

5. Study Description

Brief Summary
Empathy constitutes one prominent ability of social cognition, which represents the human capability of understanding mental state of the other, and responding in sympathetic way. Two sets of theoretical mechanisms were designed in order to explain how empathy is possible. Theory of Mind (ToM)and Simulation.People who suffer from schizophrenia frequently exhibit social dysfunction, preventing them of a normal integration in healthy human environments. Recently it had been discovered that impairment in empathy and a specific impairment in effective TOM are mostly associated with the social malfunctioning of people who suffer from schizophrenia. One of the biological substances most connected to social cognition is the neuromodulator Oxytocin. Among its known involvement in uterine contractions and lactating females, numerous recent studies have found an indispensable role for Oxytocin in various complex prosocial behaviors such as maternal behavior, attachment, partner preference and trust. In the proposed study, we plan to examine the influence of a single dose of intranasal Oxytocin on the two primary mechanisms of empathy, namely mentalizing (Theory of Mind) and Simulation, both in healthy people and in people who suffer from schizophrenia.
Detailed Description
Social cognition encompasses a wide spectrum of abilities, enabling us to function properly in interpersonal interactions. Empathy constitutes one prominent ability of social cognition, which represents the human capability of understanding mental state of the other, and responding in sympathetic way (Leiberg & Anders, 2006). Two sets of theoretical mechanisms were designed in order to explain how empathy is possible. Theory of Mind (ToM) is usually regarded as a more cognitive mechanism of empathy, in which a theory we posses regarding the other enable us to infer his mental state. 'Simulation' processing is another different mechanism of empathy. In contrast to the ToM perspective, the simulation perspective asserts that understanding the other's state of mind is achieved by an inner representation of that mental state in our mind, thus simulating his mental state. Therefore, the simulation theory may be associated with more affective aspects of empathy. Schizophrenia encompasses a wide spectrum of psychotic disorders, characterized by severe cognitive, emotional and behavioral impairments. People who suffer from schizophrenia frequently exhibit social dysfunction, preventing them of a normal integration in healthy human environments. Recently it had been discovered that impairment in empathy and a specific impairment in effective TOM are mostly associated with the social malfunctioning of people who suffer from schizophrenia. One of the biological substances most connected to social cognition is the neuromodulator Oxytocin. Among its known involvement in uterine contractions and lactating females, numerous recent studies have found an indispensable role for Oxytocin in various complex prosocial behaviors such as maternal behavior, attachment, partner preference and trust. It was suggested that Oxytocin may mediate the beneficial affect of social support, and is found strongly involved in different kinds of attachment. In a recent study, Domes et al. (2006) found that an intranasal administration of a single dose of Oxytocin enhanced the ability to infer mental states as conveyed by the eyes region (RMET, Baron-Cohen et al. 1995). These findings suggest a mediating role for the ability to use social cues in order to infer the other mental states. In the proposed study, we plan to examine the influence of a single dose of intranasal Oxytocin on the two primary mechanisms of empathy, namely mentalizing (Theory of Mind) and Simulation, both in healthy people and in people who suffer from schizophrenia. Mentalizing will be assessed by a variation of a validated ToM task, which requires cognitive and affective mentalizing. Simulation will be tested in two different tasks: emotion recognition via a dynamic paradigm of facial expressions, and recognition of biological motion, which necessitates the identification of the emotion conveyed in a video clips of point light walkers. Both of these latter tasks have been associated with simulation processing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
ToM, Theory of Mind, Simulation, Empathy, Oxytocin, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oxytocin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Oxytocin (also: syntocinon, pitocin)
Other Intervention Name(s)
Novartis.
Intervention Description
24 IU for each subject (3 puffs in each nostril, 4 IU in each puff). each subject will receive a single administration, 40 minuets before task start time.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Weleda
Intervention Description
saline liquid, intranasally administered
Primary Outcome Measure Information:
Title
accuracy level (in percentage) and reaction time (in milliseconds) of emotional facial expressions recognition in a dynamic emotional facial expressions task.
Time Frame
end of second trial for each subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (for schizophrenic patients): Range of age between 18 and 45 years. The patient is diagnosed as suffering from schizophrenia by 2 independent psychiatrists, according to DSM-IV criteria. The participant is able to commit to 2 trials with 7 days interval. The participant has been informed orally and in writing and has given his/her written consent. When necessary, a psychiatrist has determined the patient's ability to agree, orally and in writing. Inclusion Criteria (for healthy patients): Range of age between 18 and 45 years. The participant is able to commit to 2 trials with 7 days interval. The participant has been informed orally and in writing and Has given his/her written consent. Exclusion Criteria (for schizophrenic patients): The participant is suffering from other acute, unstable, significant or untreated medical Illness, including arrhythmia and head injury. The participant is suffers from an axis II disorder of DSM-IV. The participant has history of alcohol or drug abuse. The participant is pregnant or breast-feeding. The participant suffers from mental retardation (IQ less than 75). The participant has any disturbance in visuomotor coordination. The participant has smoked a cigarette in the day of the trial. High suicidal risk, as determined by the treating physician. Exclusion Criteria (for healthy patients): The participant is suffering from acute, unstable, significant or untreated medical Illness, including arrhythmia and head injury. The participant has history of alcohol or drug abuse. The participant is pregnant or breast-feeding. The participant suffers from mental retardation (IQ less than 75). The participant has any disturbance in visuomotor coordination. The participant has smoked a cigarette in the day of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meytal Fischer, Phd. Student
Phone
972-9-7478644
Email
meytal.fischer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Simone Shamay-Tsoory, MA
Phone
972-4-8288778
Email
sshamay@psy.haifa.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simone Shamay-Tsoory, MA
Organizational Affiliation
University of Haifa
Official's Role
Study Director
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD
Phone
972-9-7478697
Email
ylevk@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yechiel Levkovitz, MD

12. IPD Sharing Statement

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The Effect of Intranasal Administration of Oxytocin on Empathic Abilities.

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