The Effect of Intranasal Administration of Oxytocin on Empathic Abilities.

NCT00813436 | Unknown Phase 2

• 1 other identifier: 0007-07-SHA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

ToM; Theory of Mind; Simulation; Empathy; Oxytocin; Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

  end of second trial for each subject

Study Arms (2)

1

EXPERIMENTAL

Oxytocin

Drug: Oxytocin (also: syntocinon, pitocin)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Oxytocin (also: syntocinon, pitocin) 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.

Also known as: Novartis.

1

Placebo DRUG

saline liquid, intranasally administered

Also known as: Weleda

2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• University of Haifa: collaborator

Study Sites (1)

Shalvata Mental Health Center

Hod HaSharon, Israel

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin; lactitol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Yechiel Levkovitz, MD

  Shalvata Mental Health Center

  PRINCIPAL INVESTIGATOR

• Simone Shamay-Tsoory, MA

  University of Haifa

  STUDY DIRECTOR

Central Study Contacts

Meytal Fischer, Phd. Student

CONTACT

972-9-7478644; meytal.fischer@gmail.com

Simone Shamay-Tsoory, MA

CONTACT

972-4-8288778; sshamay@psy.haifa.ac.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 5, 2009

Record last verified: 2008-12

Locations

IL (1)