Early Phase 1
N=26
Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
Social Perception
Bottom Line
View on ClinicalTrials.gov: NCT02238379 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Amplitude Social — -3.72; -3.55; -3.28; -3.30 microvolts — p=.003
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Oxytocin (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amplitude Social |
-3.72; -3.55; -3.28; -3.30; -3.70; -3.27 | .003 sig |
| PRIMARY Amplitude Non-Social |
-1.15; -1.15; 1.21; 0.86; -0.58; -0.32 | >.14 |
| PRIMARY Latency Social |
164; 164; 163; 161; 164; 163 | .006 sig |
| PRIMARY Latency Non-Social |
171; 174; 166; 169 | .03 sig |
| SECONDARY Depression |
4.00; 4.33 | .05 |
| SECONDARY Smoking |
1; 0; 0; 0 | — |
| SECONDARY Anxiety |
31.54; 35.50; 30.58; 30.79 | .05 |
| SECONDARY Stress |
17.54; 18.13 | .05 |
| SECONDARY Early Experience |
30.13; 29.50; 27.74; 28.13; 13.71; 13.75 | .05 |
| SECONDARY Number of Participants Endorsing Substance Use |
0; 2 | — |
| SECONDARY Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02238379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.