Social PerceptionEarly Phase 1NCT02238379

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

A Early Phase 1 study testing Oxytocin in people with Social Perception, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for: Social Perception
What is being tested?: Oxytocin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Dec 2015
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Child Study Center
New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Oxytocin Pilot: Oxytocin and Face Perception

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
Being tested: Oxytocin, Placebo
Keywords: Intranasal oxytocin, Social perception, EEG/ERP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Pitocin
24 International Units of Oxytocin in a Nasal Spray
PlaceboOther
Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.

Study groups in NCT02238379
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of 30 minutes

Secondary outcomes (7)

Depression
The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).
Measured: Within 20 minutes of study visit commencing
Smoking
Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.
Measured: Within 30 minutes of study visit commencing
Anxiety
The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.
Measured: Within 20 minutes of study visit commencing
Stress
The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.
Measured: Within 20 minutes of study visit commencing
Early Experience
The investigators will employ the Parental Bonding Instrument (Parker, Tupling, \& Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from "very like" to "very unlike". The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39.
Measured: Within 20 minutes of study visit commencing
Number of Participants Endorsing Substance Use
The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, \& O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.
Measured: Within 30 minutes of study visit commencing
Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
Measured: Within 30 minutes of study visit commencing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2015

First posted12 Sep 2014 (estimated)
Study startSep 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Social PerceptionStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02238379
Sponsor's protocol ID: 1309012677
Status last verified: Jan 2018
First submitted: 4 Sep 2014
Last updated: 17 Jan 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Social Perception trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oxytocin Pilot: Oxytocin and Face Perception
ClinicalTrials.gov ID: NCT02238379
Acronym / sponsor ID: 1309012677
Conditions: Social Perception
Keywords: Intranasal oxytocin, Social perception, EEG/ERP
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Anna Freud
Study start: Sep 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 25 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Oxytocin	Experimental	Drug: OxytocinEach participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Placebo	Placebo comparator	Other: PlaceboEach participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Who may qualify

Ages: 18 to 64 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxytocinAlso: Pitocin24 International Units of Oxytocin in a Nasal Spray	Drug	Oxytocin
PlaceboPlacebo will contain all ingredients except the active oxytocin in the Nasal Spray.	Other	Placebo

Primary outcome

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.
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.
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.
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.

7 secondary outcomes

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

Results and safety

Results posted to the registry on 25 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxytocin First, Then Placebo	12	11
Placebo First, Then Oxytocin	14	14

Primary outcome: Amplitude Social

Time frame: Duration of 30 minutes. Mean (Standard Deviation). Unit: microvolts

Measure	Oxytocin n = 24	Placebo n = 24
N170 Infant Distress Faces	-3.72 (2.81)	-3.55 (2.64)
N170 Infant Neutral	-3.28 (2.55)	-3.30 (2.94)
N170 Adult Distress	-3.70 (2.72)	-3.27 (2.64)
N170 Adult Neutral	-3.23 (2.48)	-2.87 (2.33)
P300 Infant Distress Face	0.94 (1.26)	0.50 (1.21)
P300 Infant Neutral Face	1.10 (1.47)	0.55 (1.34)
P300 Adult Distress Face	0.65 (1.22)	0.39 (0.91)
P300 Adult Neutral Face	0.52 (1.38)	0.61 (1.09)

Oxytocin vs Placebo: p = .003, ANOVA
Oxytocin vs Placebo: p = .034, ANOVA
Oxytocin vs Placebo: p = .03, ANOVA

Population analysed: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms

Primary outcome: Amplitude Non-Social

Time frame: Duration of 30 minutes. Mean (Standard Deviation). Unit: microvolts

Measure	Oxytocin n = 24	Placebo n = 24
N170 House	-1.15 (1.71)	-1.15 (1.35)
P300 House	1.21 (1.47)	0.86 (0.91)
LPP House	-0.58 (1.12)	-0.32 (1.06)

Oxytocin vs Placebo: p >.14, ANOVA
Oxytocin vs Placebo: p >.17, t-test, 2 sided
Oxytocin vs Placebo: p >.27, t-test, 2 sided

Population analysed: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)

Primary outcome: Latency Social

Time frame: Duration of 30 minutes. Mean (Standard Deviation). Unit: milliseconds

Measure	Oxytocin n = 23	Placebo n = 23
N170 Infant Distress	164 (8)	164 (10)
N170 Infant Neutral	163 (9)	161 (9)
N170 Adult Distress	164 (10)	163 (12)
N170 Adult Neutral	161 (9)	161 (11)
Left N170 Infant Distress	165 (9)	166 (10)
Right N170 Infant Distress	164 (8)	162 (9)
Left N170 Infant Neutral	165 (11)	163 (10)
Right N170 Infant Neutral	161 (7)	160 (9)

Oxytocin vs Placebo: p = .006, ANOVA
Oxytocin vs Placebo: p = .01, ANOVA

Population analysed: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis

Primary outcome: Latency Non-Social

Time frame: Duration of 30 minutes. Mean (Standard Deviation). Unit: milliseconds

Measure	Oxytocin n = 23	Placebo n = 23
Left N170 House	171 (13)	174 (14)
Right N170 House	166 (9)	169 (13)

Oxytocin vs Placebo: p = .03, ANOVA
Oxytocin vs Placebo: p = .008, ANOVA

Population analysed: 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxytocin	0 of 26 (0%)	0 of 26 (0%)	Not reported
Placebo	0 of 25 (0%)	0 of 25 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Linda C Mayes, MD principal investigator

Yale University

Helena JV Rutherford, PhD study director

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Oxytocin in people with Social Perception, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude Social (time frame: Duration of 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02238379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.