Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
12. ledna 2018 aktualizováno: Yale University
Oxytocin Pilot: Oxytocin and Face Perception
The objective of this study is to investigate the effects of oxytocin on social behavior and brain activity using EEG and the event-related potential (ERP) technique.
The value of EEG is its high temporal specificity, enabling precision in the timing of social behavior to be addressed.
In order to elicit social responses in the human brain, a variety of social and emotional visual stimuli will be presented during EEG recording, namely infant and adult faces and houses.
Brain responses after intranasal oxytocin will then be compared with placebo, to examine the effect of intranasal oxytocin on central nervous system activity.
We hypothesize that intranasal oxytocin will enhance the neural response to social stimuli (infant and adult faces) but not to non-social stimuli (houses).
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
26
Fáze
- Raná fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Yale Child Study Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 64 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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24 International Units of Oxytocin in a Nasal Spray
Ostatní jména:
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Komparátor placeba: 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.
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Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Amplitude Social
Časové okno: Duration of 30 minutes
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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.
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Duration of 30 minutes
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Amplitude Non-Social
Časové okno: Duration of 30 minutes
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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.
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Duration of 30 minutes
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Latency Social
Časové okno: Duration of 30 minutes
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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.
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Duration of 30 minutes
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Latency Non-Social
Časové okno: Duration of 30 minutes
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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.
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Duration of 30 minutes
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Depression
Časové okno: Within 20 minutes of study visit commencing
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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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Within 20 minutes of study visit commencing
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Smoking
Časové okno: Within 30 minutes of study visit commencing
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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.
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Within 30 minutes of study visit commencing
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Anxiety
Časové okno: Within 20 minutes of study visit commencing
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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.
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Within 20 minutes of study visit commencing
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Stress
Časové okno: Within 20 minutes of study visit commencing
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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.
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Within 20 minutes of study visit commencing
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Early Experience
Časové okno: Within 20 minutes of study visit commencing
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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.
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Within 20 minutes of study visit commencing
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Number of Participants Endorsing Substance Use
Časové okno: Within 30 minutes of study visit commencing
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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.
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Within 30 minutes of study visit commencing
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Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer
Časové okno: Within 30 minutes of study visit commencing
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Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.
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Within 30 minutes of study visit commencing
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Linda C Mayes, MD, Yale University
- Ředitel studie: Helena JV Rutherford, PhD, Yale University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2014
Primární dokončení (Aktuální)
1. prosince 2015
Dokončení studie (Aktuální)
1. prosince 2015
Termíny zápisu do studia
První předloženo
4. září 2014
První předloženo, které splnilo kritéria kontroly kvality
9. září 2014
První zveřejněno (Odhad)
12. září 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. ledna 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. ledna 2018
Naposledy ověřeno
1. ledna 2018
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1309012677
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