The Effect of Intranasal Administration of Oxytocin on Empathic Abilities.

NCT ID: NCT00813436

Last Updated: 2009-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-01-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Oxytocin

Group Type: EXPERIMENTAL

Oxytocin (also: syntocinon, pitocin)

Intervention Type: DRUG

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.

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

saline liquid, intranasally administered

Interventions

Oxytocin (also: syntocinon, pitocin)

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

Placebo

saline liquid, intranasally administered

Intervention Type: DRUG

Other Intervention Names

Novartis.; Weleda

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Haifa

OTHER

Sponsor Role: collaborator

Shalvata Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Shalvata Mental Health Center

Principal Investigators

Yechiel Levkovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Shalvata Mental Health Center

Simone Shamay-Tsoory, MA

Role: STUDY_DIRECTOR

University of Haifa

Locations

Shalvata Mental Health Center

Hod HaSharon, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Meytal Fischer, Phd. Student

Role: CONTACT

meytal.fischer@gmail.com

972-9-7478644

Simone Shamay-Tsoory, MA

Role: CONTACT

sshamay@psy.haifa.ac.il

972-4-8288778

Facility Contacts

Yechiel Levkovitz, MD

Role: primary

ylevk@clalit.org.il

972-9-7478697

Other Identifiers

0007-07-SHA

Identifier Type: -

Identifier Source: org_study_id