Intranasal Oxytocin Administration and the Neural Correlates of Social and Non-Social Visual Perception
12 de janeiro de 2018 atualizado por: 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).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
26
Estágio
- Fase inicial 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale Child Study Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 64 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: 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
Outros nomes:
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Comparador de 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Amplitude Social
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Depression
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Linda C Mayes, MD, Yale University
- Diretor de estudo: Helena JV Rutherford, PhD, Yale University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2014
Conclusão Primária (Real)
1 de dezembro de 2015
Conclusão do estudo (Real)
1 de dezembro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
4 de setembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de setembro de 2014
Primeira postagem (Estimativa)
12 de setembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de janeiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de janeiro de 2018
Última verificação
1 de janeiro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1309012677
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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