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| Name | Class |
|---|---|
| Anna Freud | OTHER |
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 24 International Units of Oxytocin in a Nasal Spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda C Mayes, MD | Yale University | Principal Investigator |
| Helena JV Rutherford, PhD | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin First, Then Placebo | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Oxytocin: 24 International Units of Oxytocin in a Nasal Spray |
| FG001 | Placebo First, Then Oxytocin | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 participant was lost to follow up for their placebo visit (determined after blind was broken).
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Oxytocin: 24 International Units of Oxytocin in a Nasal Spray |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | microvolts | Duration of 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxytocin | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Oxytocin: 24 International Units of Oxytocin in a Nasal Spray |
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Small sample size limiting the interpretations of ERP differences between oxytocin and placebo conditions and individual difference measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helena Rutherford | Yale University | 203-737-3408 | helena.rutherford@yale.edu |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Other | Placebo will contain all ingredients except the active oxytocin in the Nasal Spray. |
|
| Duration of 30 minutes |
| 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. | 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. | 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. | 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. | 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. | 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. | Within 30 minutes of study visit commencing |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray. |
|
|
|
| Primary | 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. | 1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms) | Posted | Mean | Standard Deviation | microvolts | Duration of 30 minutes |
|
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | milliseconds | Duration of 30 minutes |
|
|
|
|
| Primary | 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. | 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 | Posted | Mean | Standard Deviation | milliseconds | Duration of 30 minutes |
|
|
|
|
| Secondary | 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). | Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss) | Posted | Mean | Standard Deviation | units on a scale | Within 20 minutes of study visit commencing |
|
|
|
|
| Secondary | 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. | 1 participant was lost to follow-up | Posted | Count of Participants | Participants | Within 30 minutes of study visit commencing |
|
|
|
| Secondary | 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. | Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss) | Posted | Mean | Standard Deviation | units on a scale | Within 20 minutes of study visit commencing |
|
|
|
|
| Secondary | 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. | Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss) | Posted | Mean | Standard Deviation | units on a scale | Within 20 minutes of study visit commencing |
|
|
|
|
| Secondary | 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | Within 20 minutes of study visit commencing |
|
|
|
|
| Secondary | 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. | 1 participant lost to follow-up; count of participants where substance dependence indicated | Posted | Count of Participants | Participants | Within 30 minutes of study visit commencing |
|
|
|
| Secondary | 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. | 1 participant lost to follow-up; data indicates number of participants with alcohol in their system | Posted | Count of Participants | Participants | Within 30 minutes of study visit commencing |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design. Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray. | 0 | 25 | 0 | 25 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| LPP House |
|
P300 Analysis
| t-test, 2 sided |
Paired samples t-test comparing Spray Type (Oxytocin vs Placebo) |
| >.17 |
No difference between Spray Types |
| Superiority or Other |
| LPP Analysis | t-test, 2 sided | Paired samples t-test comparing Spray Type (Oxytocin vs Placebo) | >.27 | No difference between Spray Types | Superiority or Other |
| N170 Adult Distress |
|
| N170 Adult Neutral |
|
| Left N170 Infant Distress |
|
| Right N170 Infant Distress |
|
| Left N170 Infant Neutral |
|
| Right N170 Infant Neutral |
|
| Left N170 Adult Distress |
|
| Right N170 Adult Distress |
|
| Left N170 Adult Neutral |
|
| Right N170 Adult Neutral |
|
Only relevant for N170 |
| ANOVA |
Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA |
| .01 |
Main Effect of Hemisphere |
| Superiority or Other |
| ANOVA |
Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA |
| .008 |
Main Effect of Hemisphere |
| Superiority or Other |
| Paternal Care Score |
|
|
| Maternal Protectiveness Score |
|
|
| Paternal Protectiveness Score |
|
|