Oxytocin, Emotions and Mirror Neurons

NCT02228031 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HP-00059904
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.

Conditions

Social Cognition; Expressed Emotion

Keywords

Mirror neurons; Imitation; Oxytocin

Outcome Measures

Primary Outcomes (1)

• EEG mu rhythm suppression

  The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and \~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.

  Before oxytocin/placebo administration and 45 minutes after

Study Arms (2)

Oxytocin

EXPERIMENTAL

The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.

Other: Placebo

Interventions

Oxytocin DRUG

The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session

Also known as: Syntocinon nasal spray

Oxytocin

Placebo OTHER

The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-hand dominant
• Sufficient spoken English so as to be able to complete testing validly and give informed consent

You may not qualify if:

• Currently taking any psychotropic or cognition enhancing medication
• History of schizophrenia or any other psychotic disorder, including Bipolar Disorder
• Family history of psychosis
• Neurological disease or clinically significant head injury
• Physical disability that substantially impairs motor function
• Current diagnosis of polydypsic-induced hyponatremia
• Substance dependence or abuse in the past 6 months

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

Child Development Lab, University of Maryland

College Park, Maryland, 20742, United States

Location

Related Publications (1)

• Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. doi: 10.1073/pnas.0935845100. Epub 2003 Apr 7.

  PMID: 12682281 BACKGROUND

MeSH Terms

Interventions

Oxytocin

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

• Robert W Buchanan, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Nathan Fox, PhD

  University of Maryland, College Park

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Director, Maryland Psychiatric Research Center

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 28, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)