- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05968651
Aprendizagem de Segurança Social no Sistema Cerebral de Oxitocina
10 de junho de 2026 atualizado por: Angela Fang, University of Washington
Os investigadores estão conduzindo este estudo de pesquisa para examinar se a oxitocina aumenta o aprendizado de segurança social (aprender a segurança por meio da experiência de outro indivíduo) em pessoas com transtorno de ansiedade social (TAS) em comparação com voluntários saudáveis.
A ocitocina é um hormônio que também pode atuar como um mensageiro químico no cérebro.
A ocitocina desempenha um papel em várias funções, incluindo a resposta ao medo e às interações sociais.
Neste estudo, os investigadores gostariam de comparar os efeitos dos sprays nasais de oxitocina e placebo em adultos com SAD e adultos saudáveis.
Este estudo de pesquisa irá comparar um spray nasal de oxitocina com um spray nasal de placebo.
Cerca de 120 pessoas participarão desta pesquisa, todas na Universidade de Washington (UW).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
O objetivo do estudo atual é examinar o papel potencial da oxitocina na melhoria da aprendizagem social no SAD.
A principal hipótese dos pesquisadores é que o aprendizado de extinção vicária contribuirá para o aprendizado seguro e que a oxitocina potencializará o aprendizado de extinção vicária em pacientes com SAD, em comparação com controles saudáveis (HC).
Os pesquisadores testarão diretamente o efeito da oxitocina intranasal e do placebo correspondente nos mecanismos cerebrais subjacentes ao aprendizado de extinção vicária usando uma nova tarefa.
60 adultos com SAD e 60 participantes de controle saudáveis realizarão uma tarefa que envolve três fases: (i) um procedimento padrão de aquisição de medo social enquanto estiver em um scanner simulado, seguido por (ii) uma extinção vicária e (iii) procedimento de teste de reintegração de medo, durante a varredura durante a ressonância magnética funcional (fMRI).
Os participantes receberão ocitocina ou placebo antes da fase de extinção.
Os investigadores também medirão as respostas de condutância da pele como um índice de aprendizado em cada fase.
Tipo de estudo
Intervencional
Inscrição (Real)
121
Estágio
- Fase 2
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
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- University of Washington
-
-
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
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Critério de inclusão:
Para Amostra Clínica
- Homens e mulheres de 18 a 45 anos
- As mulheres devem ter ciclos menstruais regulares e não estar tomando anticoncepcionais orais
- Diagnóstico primário de transtorno de ansiedade social
Para Amostra Saudável
- Homens e mulheres de 18 a 45 anos
- As mulheres devem ter ciclos menstruais regulares e não estar tomando anticoncepcionais orais
- Sem história atual ou vitalícia de distúrbios psiquiátricos, neurológicos ou médicos
Critério de exclusão:
Para todos os grupos
- Gravidez ou amamentação
- Resultado positivo do teste de triagem de drogas na urina
- História da patologia nasal
- Uso atual de qualquer medicamento psicotrópico ou esteroides
- Transtorno por uso de substância ativa nos últimos 6 meses
- Histórico de doenças médicas graves ou doenças endócrinas não tratadas
- Histórico de traumatismo craniano, distúrbio neurológico ou procedimento neurocirúrgico
- Tela de ressonância magnética positiva (MR)
Para Amostra Clínica
- Diagnósticos ao longo da vida de mania ou transtorno psicótico com base no Manual Diagnóstico e Estatístico (DSM-5ª ed)
- Ideação suicida aguda
Para Amostra Saudável
- Diagnóstico vitalício DSM-5 de qualquer doença médica, neurológica ou psiquiátrica
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: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Clínico
Este grupo consiste em indivíduos com pelo menos sintomas moderados de transtorno de ansiedade social.
Este grupo receberá uma administração de ocitocina ou placebo (randomização cega).
|
Single acute administration of 24 international units (IU) oxytocin or matching placebo
|
|
Comparador de Placebo: Controles
Este grupo consiste em uma amostra saudável de indivíduos (sem diagnósticos de mania ou transtornos psicóticos ao longo da vida).
Este grupo receberá uma administração de ocitocina ou placebo (randomização cega).
|
Single acute administration of 24 international units (IU) oxytocin or matching placebo
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Hippocampus During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Amygdala During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS- During Extinction
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS- stimuli during Extinction
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS+S During Extinction
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS+S stimuli during Extinction
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS+R During Extinction
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS+R stimuli during Extinction
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS- During Reinstatement
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS- stimuli during Reinstatement
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS+S During Reinstatement
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS+S stimuli during Reinstatement
|
immediately (45 minutes) after receiving drug
|
|
Skin Conductance Responses (SCR) to CS+R During Reinstatement
Prazo: immediately (45 minutes) after receiving drug
|
mean skin conductance responses (SCR) for CS+R stimuli during Reinstatement
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Amygdala During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Insula During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Hippocampus During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during vicarious extinction (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS- (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during vicarious extinction (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during vicarious extinction (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during vicarious extinction (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Extinction Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during vicarious extinction (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Amygdala During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the amygdala region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Insula During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the insula during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the insula region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Hippocampus During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the hippocampus during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the hippocampus region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Anterior Cingulate Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the anterior cingulate cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the anterior cingulate cortex region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+S vs CS- Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the ventromedial prefrontal cortex during fear reinstatement, which tests the return of fear (specifically for CS+S versus CS- conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
A lack of difference between these two task conditions is desirable, indicating processing both task conditions as safety cues.
|
immediately (45 minutes) after receiving drug
|
|
Neural Responses in the CS+R vs CS+S Contrast in the Ventromedial Prefrontal Cortex During the Reinstatement Phase
Prazo: immediately (45 minutes) after receiving drug
|
Change in task-related blood oxygen level dependent (BOLD) responses in the amygdala during fear reinstatement, which tests for the return of fear (specifically for CS+R (reinforced) versus CS+S (non-reinforced) conditions).
Changes in BOLD responses refer to differences in neural responses between these two task conditions, which were extracted from the ventromedial prefrontal cortex region of interest and estimated using a general linear model.
Higher mean responses reflect greater discrimination (better able to distinguish between threat and safety cues) between the task conditions.
|
immediately (45 minutes) after receiving drug
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
respostas de condutância da pele (SCR) a sugestão extinta indiretamente versus sugestão reforçada indiretamente durante a reintegração
Prazo: logo após a intervenção
|
SCR médio para CS- versus CS+
|
logo após a intervenção
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Angela Fang, PhD, University of Washington
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 (Real)
26 de junho de 2023
Conclusão Primária (Real)
30 de setembro de 2024
Conclusão do estudo (Real)
30 de setembro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
10 de julho de 2023
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de julho de 2023
Primeira postagem (Real)
1 de agosto de 2023
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2026
Última verificação
1 de março de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00013670
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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