Clinical trial NCT02238379: Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
Official title: Oxytocin Pilot: Oxytocin and Face Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Social Perception
Keywords: Intranasal oxytocin
Social perception
EEG/ERP
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Anna Freud
First posted: 2014-09-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


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

Primary outcomes:
measure: Amplitude Social
timeFrame: Duration of 30 minutes
measure: Amplitude Non-Social
timeFrame: Duration of 30 minutes
measure: Latency Social
timeFrame: Duration of 30 minutes
measure: Latency Non-Social
timeFrame: Duration of 30 minutes
Secondary outcomes:
measure: Depression
timeFrame: Within 20 minutes of study visit commencing
measure: Smoking
timeFrame: Within 30 minutes of study visit commencing
measure: Anxiety
timeFrame: Within 20 minutes of study visit commencing
measure: Stress
timeFrame: Within 20 minutes of study visit commencing
measure: Early Experience
timeFrame: Within 20 minutes of study visit commencing
measure: Number of Participants Endorsing Substance Use
timeFrame: Within 30 minutes of study visit commencing
measure: Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
timeFrame: Within 30 minutes of study visit commencing
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Linda C Mayes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Helena JV Rutherford, PhD
role: STUDY_DIRECTOR
References: