## Protocol Section
### Identification Module
**NCT ID:** NCT02238379

**Brief Title:** Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception

**Official Title:** Oxytocin Pilot: Oxytocin and Face Perception

#### Organization Study ID Info
**ID:** 1309012677
#### Organization
**Class:** OTHER
**Full Name:** Yale University
### Status Module
#### Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-01-17

**Type:** ACTUAL

**Last Update Submit Date:** 2018-01-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-05-25

**Type:** ACTUAL

**Results First Submit Date:** 2016-11-28

**Results First Submit QC Date:** 2017-05-19

#### Start Date
**Date:** 2014-09

**Status Verified Date:** 2018-01

#### Study First Post Date
**Date:** 2014-09-12
**Type:** ESTIMATED
**Study First Submit Date:** 2014-09-04
**Study First Submit QC Date:** 2014-09-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Anna Freud Centre

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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 Module

**Conditions:**

- Social Perception

**Keywords:**

- Intranasal oxytocin

- Social perception

- EEG/ERP

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Drug: Oxytocin

**Label:** Oxytocin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Oxytocin

**Description:** 24 International Units of Oxytocin in a Nasal Spray

**Name:** Oxytocin

**Other Names:**

- Pitocin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

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

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Amplitude Social

**Time Frame:** Duration of 30 minutes

**Description:** 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.

**Measure:** Amplitude Non-Social

**Time Frame:** Duration of 30 minutes

**Description:** 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.

**Measure:** Latency Social

**Time Frame:** Duration of 30 minutes

**Description:** 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.

**Measure:** Latency Non-Social

**Time Frame:** Duration of 30 minutes

#### Secondary Outcomes

**Description:** 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).

**Measure:** Depression

**Time Frame:** Within 20 minutes of study visit commencing

**Description:** 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.

**Measure:** Smoking

**Time Frame:** Within 30 minutes of study visit commencing

**Description:** 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.

**Measure:** Anxiety

**Time Frame:** Within 20 minutes of study visit commencing

**Description:** 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.

**Measure:** Stress

**Time Frame:** Within 20 minutes of study visit commencing

**Description:** 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.

**Measure:** Early Experience

**Time Frame:** Within 20 minutes of study visit commencing

**Description:** 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.

**Measure:** Number of Participants Endorsing Substance Use

**Time Frame:** Within 30 minutes of study visit commencing

**Description:** Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.

**Measure:** Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer

**Time Frame:** Within 30 minutes of study visit commencing

### Eligibility Module

**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

**Healthy Volunteers:** True

**Maximum Age:** 64 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New Haven

**Country:** United States

**Facility:** Yale Child Study Center

**State:** Connecticut

**Zip:** 06520

#### Overall Officials

**Official 1:**

**Affiliation:** Yale University

**Name:** Linda C Mayes, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Yale University

**Name:** Helena JV Rutherford, PhD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000010120

- Term: Oxytocics

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13041

- Name: Oxytocin

- Relevance: HIGH

- As Found: Joint

### Intervention Browse Module - Meshes

- ID: D000010121

- Term: Oxytocin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Oxytocin

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

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray

**ID:** EG000

**Other Num at Risk:** 26

**Serious Number At Risk:** 26

**Title:** Oxytocin

**Group ID:** EG001

**Title:** Placebo

**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.

**ID:** EG001

**Other Num at Risk:** 25

**Serious Number At Risk:** 25

**Title:** Placebo

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 12

**Group ID:** BG001

**Value:** 14

**Group ID:** BG002

**Value:** 26

**Units:** Participants

### Group

**ID:** BG000

**Title:** Oxytocin

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

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 26

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 3

**Value:** 24

#### Measurement

**Group ID:** BG001

**Spread:** 3

**Value:** 23

#### Measurement

**Group ID:** BG002

**Spread:** 3

**Value:** 24

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 26

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 26

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** 1 participant was lost to follow up for their placebo visit (determined after blind was broken).
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Limitations and Caveats
**Description:** Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.
### Point of Contact
**Email:** helena.rutherford@yale.edu
**Organization:** Yale University
**Phone:** 203-737-3408
**Title:** Dr. Helena Rutherford
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** N170 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .003
**P-Value Comment:** Main Effect of Emotion
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** N170 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .034
**P-Value Comment:** Main Effect of Face Type
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** P300 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .03
**P-Value Comment:** Main Effect of Face Type
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** P300 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .03
**P-Value Comment:** Spray Type by Face Type Interaction
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** LPP Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** >.22
**P-Value Comment:** No Main Effects or Interactions
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** N170 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** >.14
**P-Value Comment:** No Main Effects or Interactions
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** P300 Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** >.17
**P-Value Comment:** No difference between Spray Types
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** LPP Analysis
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** >.27
**P-Value Comment:** No difference between Spray Types
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Only relevant for N170
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .006
**P-Value Comment:** Main Effect of Emotion
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Only relevant for N170
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .01
**P-Value Comment:** Main Effect of Hemisphere
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Only relevant for N170
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .03
**P-Value Comment:** Main Effect of Spray
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Only relevant for N170
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .008
**P-Value Comment:** Main Effect of Hemisphere
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** correlation
**Tested Non-Inferiority:** 
### Outcome Measure 6
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** correlation
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** correlation
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** .05
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** correlation
**Tested Non-Inferiority:** 
### Outcome Measure 10
### Outcome Measure 11
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.81
- **Upper Limit:** 
- **Value:** -3.72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.64
- **Upper Limit:** 
- **Value:** -3.55
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.55
- **Upper Limit:** 
- **Value:** -3.28
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.94
- **Upper Limit:** 
- **Value:** -3.30
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.72
- **Upper Limit:** 
- **Value:** -3.70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.64
- **Upper Limit:** 
- **Value:** -3.27
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.48
- **Upper Limit:** 
- **Value:** -3.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.33
- **Upper Limit:** 
- **Value:** -2.87
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.26
- **Upper Limit:** 
- **Value:** 0.94
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.21
- **Upper Limit:** 
- **Value:** 0.50
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.47
- **Upper Limit:** 
- **Value:** 1.10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.34
- **Upper Limit:** 
- **Value:** 0.55
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.22
- **Upper Limit:** 
- **Value:** 0.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.91
- **Upper Limit:** 
- **Value:** 0.39
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.38
- **Upper Limit:** 
- **Value:** 0.52
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.09
- **Upper Limit:** 
- **Value:** 0.61
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.53
- **Upper Limit:** 
- **Value:** -0.56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.94
- **Upper Limit:** 
- **Value:** -0.50
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** -0.24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.51
- **Upper Limit:** 
- **Value:** -0.54
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.33
- **Upper Limit:** 
- **Value:** -0.38
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.40
- **Upper Limit:** 
- **Value:** -0.57
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.49
- **Upper Limit:** 
- **Value:** -0.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.27
- **Upper Limit:** 
- **Value:** -0.40
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.71
- **Upper Limit:** 
- **Value:** -1.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.35
- **Upper Limit:** 
- **Value:** -1.15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.47
- **Upper Limit:** 
- **Value:** 1.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.91
- **Upper Limit:** 
- **Value:** 0.86
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.12
- **Upper Limit:** 
- **Value:** -0.58
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.06
- **Upper Limit:** 
- **Value:** -0.32
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8
- **Upper Limit:** 
- **Value:** 164
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 164
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 163
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 161
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 164
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12
- **Upper Limit:** 
- **Value:** 163
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 161
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 161
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 165
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 166
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8
- **Upper Limit:** 
- **Value:** 164
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 162
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 165
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 163
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7
- **Upper Limit:** 
- **Value:** 161
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 160
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11
- **Upper Limit:** 
- **Value:** 166
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14
- **Upper Limit:** 
- **Value:** 165
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 162
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 161
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 163
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** 162
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8
- **Upper Limit:** 
- **Value:** 159
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10
- **Upper Limit:** 
- **Value:** 160
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** 171
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14
- **Upper Limit:** 
- **Value:** 174
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** 166
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** 169
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.06
- **Upper Limit:** 
- **Value:** 4.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.75
- **Upper Limit:** 
- **Value:** 4.33
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.67
- **Upper Limit:** 
- **Value:** 31.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.27
- **Upper Limit:** 
- **Value:** 35.50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.11
- **Upper Limit:** 
- **Value:** 30.58
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.82
- **Upper Limit:** 
- **Value:** 30.79
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.28
- **Upper Limit:** 
- **Value:** 17.54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.23
- **Upper Limit:** 
- **Value:** 18.13
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.69
- **Upper Limit:** 
- **Value:** 30.13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.79
- **Upper Limit:** 
- **Value:** 29.50
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.67
- **Upper Limit:** 
- **Value:** 27.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.95
- **Upper Limit:** 
- **Value:** 28.13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.01
- **Upper Limit:** 
- **Value:** 13.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.51
- **Upper Limit:** 
- **Value:** 13.75
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 24
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.30
- **Upper Limit:** 
- **Value:** 11.91
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.34
- **Upper Limit:** 
- **Value:** 10.91
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 23
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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
**Reporting Status:** POSTED
**Time Frame:** Duration of 30 minutes
**Title:** Amplitude Social
**Type:** PRIMARY
**Unit of Measure:** microvolts
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)
**Reporting Status:** POSTED
**Time Frame:** Duration of 30 minutes
**Title:** Amplitude Non-Social
**Type:** PRIMARY
**Unit of Measure:** microvolts
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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
**Reporting Status:** POSTED
**Time Frame:** Duration of 30 minutes
**Title:** Latency Social
**Type:** PRIMARY
**Unit of Measure:** milliseconds
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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
**Reporting Status:** POSTED
**Time Frame:** Duration of 30 minutes
**Title:** Latency Non-Social
**Type:** PRIMARY
**Unit of Measure:** milliseconds
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Description:** 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).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
**Reporting Status:** POSTED
**Time Frame:** Within 20 minutes of study visit commencing
**Title:** Depression
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 1 participant was lost to follow-up
**Reporting Status:** POSTED
**Time Frame:** Within 30 minutes of study visit commencing
**Title:** Smoking
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
**Reporting Status:** POSTED
**Time Frame:** Within 20 minutes of study visit commencing
**Title:** Anxiety
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 8
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)
**Reporting Status:** POSTED
**Time Frame:** Within 20 minutes of study visit commencing
**Title:** Stress
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 9
**Description:** 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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment
**Reporting Status:** POSTED
**Time Frame:** Within 20 minutes of study visit commencing
**Title:** Early Experience
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 10
**Description:** 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.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 1 participant lost to follow-up; count of participants where substance dependence indicated
**Reporting Status:** POSTED
**Time Frame:** Within 30 minutes of study visit commencing
**Title:** Number of Participants Endorsing Substance Use
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 11
**Description:** Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** 1 participant lost to follow-up; data indicates number of participants with alcohol in their system
**Reporting Status:** POSTED
**Time Frame:** Within 30 minutes of study visit commencing
**Title:** Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** OG000
**Title:** Oxytocin
##### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.

Oxytocin: 24 International Units of Oxytocin in a Nasal Spray
**ID:** FG000
**Title:** Oxytocin First, Then Placebo
#### Group
**Description:** Each 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 will contain all ingredients except the active oxytocin in the Nasal Spray.
**ID:** FG001
**Title:** Placebo First, Then Oxytocin
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 14
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True