Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
12 gennaio 2018 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
26
Fase
- Prima fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06520
- Yale Child Study Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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
Altri nomi:
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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Amplitude Social
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Depression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Linda C Mayes, MD, Yale University
- Direttore dello studio: Helena JV Rutherford, PhD, Yale University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2014
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
4 settembre 2014
Primo inviato che soddisfa i criteri di controllo qualità
9 settembre 2014
Primo Inserito (Stima)
12 settembre 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 gennaio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 gennaio 2018
Ultimo verificato
1 gennaio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1309012677
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .