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Clinical Trials/NCT02238379
NCT02238379
Completed
Early Phase 1

Oxytocin Pilot: Oxytocin and Face Perception

Yale University1 site in 1 country26 target enrollmentSeptember 2014
InterventionsOxytocinPlacebo

Overview

Phase
Early Phase 1
Intervention
Oxytocin
Conditions
Social Perception
Sponsor
Yale University
Enrollment
26
Locations
1
Primary Endpoint
Latency Non-Social
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
December 2015
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

Oxytocin

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

Intervention: Oxytocin

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Latency Non-Social

Time Frame: Duration of 30 minutes

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.

Amplitude Non-Social

Time Frame: Duration of 30 minutes

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.

Amplitude Social

Time Frame: Duration of 30 minutes

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.

Latency Social

Time Frame: Duration of 30 minutes

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.

Secondary Outcomes

  • Early Experience(Within 20 minutes of study visit commencing)
  • Depression(Within 20 minutes of study visit commencing)
  • Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer(Within 30 minutes of study visit commencing)
  • Smoking(Within 30 minutes of study visit commencing)
  • Stress(Within 20 minutes of study visit commencing)
  • Number of Participants Endorsing Substance Use(Within 30 minutes of study visit commencing)
  • Anxiety(Within 20 minutes of study visit commencing)

Study Sites (1)

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