Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception

NCT02238379 | Completed Early Phase 1 Results

• 1 other identifier: 1309012677
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique. The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed. In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses. Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity. We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).

Conditions

Social Perception

Keywords

Intranasal oxytocin; Social perception; EEG/ERP

Outcome Measures

Primary Outcomes (4)

• Amplitude Social

  The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.

  Duration of 30 minutes

• Amplitude Non-Social

  The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.

  Duration of 30 minutes

• Latency Social

  The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.

  Duration of 30 minutes

• Latency Non-Social

  The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.

  Duration of 30 minutes

Secondary Outcomes (7)

• Depression

  Within 20 minutes of study visit commencing

• Smoking

  Within 30 minutes of study visit commencing

• Anxiety

  Within 20 minutes of study visit commencing

• Stress

  Within 20 minutes of study visit commencing

• Early Experience

  Within 20 minutes of study visit commencing

Study Arms (2)

Oxytocin

EXPERIMENTAL

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Other: Placebo

Interventions

Oxytocin DRUG

24 International Units of Oxytocin in a Nasal Spray

Also known as: Pitocin

Oxytocin

Placebo OTHER

Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adults ages 18-64
• Good medical health
• Ability to understand and speak English

You may not qualify if:

• Pregnancy
• Medical Illnesses: Moderate or severe acute or chronic medical illnesses (e.g. cardiac disease, diabetes, epilepsy, influenza).
• Cardiovascular risk factors: History of hypertension with baseline blood pressure above 140 mm Hg (systolic) over 90 mm Hg (diastolic). Also any history of syncope and/or baseline blood pressure below 100 mm Hg (systolic).
• CNS disease: Known history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), other central nervous system disease, or history of head trauma which resulted in a persistent neurologic deficit or loss of consciousness \> 3 minutes.
• Medication status: Individuals on stable doses of a neuroleptic and/or an antidepressant medication for at least the past 6 weeks will be allowed to participate in this study. The use of other psychotropic medications will not be allowed. Females taking contraceptive hormones will not be able to participate in the study.
• A history of seizures or current use of anticonvulsants; history of head injury with loss of consciousness

Sponsors & Collaborators

• Yale University: lead
• Anna Freud: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

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

Limitations and Caveats

Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.

Results Point of Contact

• Title: Dr. Helena Rutherford
• Organization: Yale University

helena.rutherford@yale.edu

203-737-3408

Study Officials

• Linda C Mayes, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Helena JV Rutherford, PhD

  Yale University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 12, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 17, 2018
• Results First Posted: May 25, 2017

Record last verified: 2018-01

Locations

US (1)