An Early Phase 1 interventional study of Oxytocin and Placebo in Social Perception, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
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).
Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.
Drug: 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.
Other: Placebo
24 International Units of Oxytocin in a Nasal Spray
Also known as: Pitocin
Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of 30 minutes
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 30 minutes of study visit commencing
| Milestone | Oxytocin First, Then Placebo | Placebo First, Then Oxytocin |
|---|---|---|
| Started | 12 | 14 |
| Completed | 11 | 14 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| microvolts | Oxytocin | Placebo |
|---|---|---|
| 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 |
| LPP Infant Distress Face | -0.56 ± 1.53 | -0.50 ± 0.94 |
| LPP Infant Neutral Face | -0.24 ± 1.40 | -0.54 ± 1.51 |
| LPP Adult Distress Face | -0.38 ± 1.33 | -0.57 ± 1.40 |
| LPP Adult Neutral Face | -0.71 ± 1.49 | -0.40 ± 1.27 |
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.
| microvolts | Oxytocin | Placebo |
|---|---|---|
| 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 |
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.
| milliseconds | Oxytocin | Placebo |
|---|---|---|
| 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 |
| Left N170 Adult Distress | 166 ± 11 | 165 ± 14 |
| Right N170 Adult Distress | 162 ± 9 | 161 ± 9 |
| Left N170 Adult Neutral | 163 ± 10 | 162 ± 13 |
| Right N170 Adult Neutral | 159 ± 8 | 160 ± 10 |
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.
| milliseconds | Oxytocin | Placebo |
|---|---|---|
| Left N170 House | 171 ± 13 | 174 ± 14 |
| Right N170 House | 166 ± 9 | 169 ± 13 |
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).
| units on a scale | Oxytocin | Placebo |
|---|---|---|
| Depression | 4.00 ± 6.06 | 4.33 ± 5.75 |
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.
| Participants | Oxytocin | Placebo |
|---|---|---|
| FTND indicated smoking status | 1 | 0 |
| CO indicated smoking status | 0 | 0 |
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.
| units on a scale | Oxytocin | Placebo |
|---|---|---|
| State Anxiety | 31.54 ± 10.67 | 35.50 ± 11.27 |
| Trait Anxiety | 30.58 ± 10.11 | 30.79 ± 7.82 |
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.
| units on a scale | Oxytocin | Placebo |
|---|---|---|
| Stress | 17.54 ± 8.28 | 18.13 ± 8.23 |
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.
| units on a scale | Oxytocin | Placebo |
|---|---|---|
| Maternal Care Score | 30.13 ± 6.69 | 29.50 ± 6.79 |
| Paternal Care Score | 27.74 ± 8.67 | 28.13 ± 8.95 |
| Maternal Protectiveness Score | 13.71 ± 8.01 | 13.75 ± 8.51 |
| Paternal Protectiveness Score | 11.91 ± 8.30 | 10.91 ± 9.34 |
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.
| Participants | Oxytocin | Placebo |
|---|---|---|
| Number of Participants Endorsing Substance Use | 0 | 2 |
Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
| Participants | Oxytocin | Placebo |
|---|---|---|
| Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer | 0 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxytocin | — | 0/26 (0%) | 0/26 (0%) |
| Placebo | — | 0/25 (0%) | 0/25 (0%) |
1 participant was lost to follow up for their placebo visit (determined after blind was broken).
| Age, Categorical(Participants) | Oxytocin | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Oxytocin | Placebo | Total |
|---|---|---|---|
| Mean | 24 ± 3 | 23 ± 3 | 24 ± 3 |
| Sex: Female, Male(Participants) | Oxytocin | Placebo | Total |
|---|---|---|---|
| Female | 12 | 14 | 26 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Oxytocin | Placebo | Total |
|---|---|---|---|
| United States | 12 | 14 | 26 |
The record gives a start of Sep 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in May 2017, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Oxytocin