- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05968651
Aprendizaje de seguridad social en el sistema de oxitocina cerebral
10 de junio de 2026 actualizado por: Angela Fang, University of Washington
Los investigadores están realizando este estudio de investigación para examinar si la oxitocina mejora el aprendizaje sobre seguridad social (aprendizaje sobre seguridad a través de la experiencia de otro individuo) en personas con trastorno de ansiedad social (SAD) en comparación con voluntarios sanos.
La oxitocina es una hormona que también puede actuar como mensajero químico en el cerebro.
La oxitocina desempeña un papel en una serie de funciones, incluida la respuesta al miedo y las interacciones sociales.
En este estudio, a los investigadores les gustaría comparar los efectos de los aerosoles nasales de oxitocina y placebo en adultos con TAE y adultos sanos.
Este estudio de investigación comparará un aerosol nasal de oxitocina con un aerosol nasal de placebo.
Unas 120 personas participarán en este estudio de investigación, todas en la Universidad de Washington (UW).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
El objetivo del estudio actual es examinar el papel potencial de la oxitocina en la mejora del aprendizaje social en el TAE.
La hipótesis principal de los investigadores es que el aprendizaje de extinción indirecto contribuirá al aprendizaje de seguridad y que la oxitocina potenciará el aprendizaje de extinción indirecto en pacientes con SAD, en comparación con los controles sanos (HC).
Los investigadores probarán directamente el efecto de la oxitocina intranasal y el placebo correspondiente en los mecanismos cerebrales que subyacen al aprendizaje indirecto de la extinción mediante una tarea novedosa.
60 adultos con SAD y 60 participantes de control sanos realizarán una tarea que consta de tres fases: (i) un procedimiento estándar de adquisición de miedo social mientras están en un escáner simulado, seguido de (ii) una extinción vicaria y (iii) procedimiento de prueba de restablecimiento del miedo, mientras se escanea durante la resonancia magnética funcional (fMRI).
Los participantes recibirán oxitocina o placebo antes de la fase de extinción.
Los investigadores también medirán las respuestas de conductancia de la piel como un índice de aprendizaje en cada fase.
Tipo de estudio
Intervencionista
Inscripción (Actual)
121
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- University of Washington
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión:
Para muestra clínica
- Hombres y mujeres de 18 a 45 años
- Las mujeres deben tener ciclos menstruales regulares y no estar tomando anticonceptivos orales.
- Diagnóstico primario de trastorno de ansiedad social
Para muestra saludable
- Hombres y mujeres de 18 a 45 años
- Las mujeres deben tener ciclos menstruales regulares y no estar tomando anticonceptivos orales.
- Sin antecedentes actuales o de por vida de trastornos psiquiátricos, neurológicos o médicos
Criterio de exclusión:
Para todos los grupos
- Embarazo o lactancia
- Resultado positivo de la prueba de detección de drogas en orina
- Historia de la patología nasal
- Uso actual de cualquier medicamento psicotrópico o esteroides
- Trastorno por consumo de sustancias activas en los últimos 6 meses
- Antecedentes de enfermedades médicas graves o enfermedades endocrinas no tratadas
- Antecedentes de lesión en la cabeza, trastorno neurológico o procedimiento neuroquirúrgico
- Pantalla de resonancia magnética positiva (MR)
Para muestra clínica
- Diagnósticos de por vida de manía o trastorno psicótico basados en el Manual Diagnóstico y Estadístico (DSM-5th ed)
- Ideación suicida aguda
Para muestra saludable
- Diagnóstico de por vida del DSM-5 de cualquier enfermedad médica, neurológica o psiquiátrica
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Clínico
Este grupo está formado por personas con síntomas al menos moderados del trastorno de ansiedad social.
Este grupo recibirá una administración de oxitocina o de placebo (aleatorización ciega).
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Single acute administration of 24 international units (IU) oxytocin or matching placebo
|
|
Comparador de placebos: Control S
Este grupo consiste en una muestra sana de individuos (sin diagnósticos de por vida de manía o trastornos psicóticos).
Este grupo recibirá una administración de oxitocina o de placebo (aleatorización ciega).
|
Single acute administration of 24 international units (IU) oxytocin or matching placebo
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Neural Responses in the CS+R vs CS+S Contrast in the Insula During the Extinction Phase
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
respuestas de conductancia de la piel (SCR) a la señal indirectamente extinguida frente a la señal indirectamente reforzada durante el restablecimiento
Periodo de tiempo: inmediatamente después de la intervención
|
SCR medio para CS- versus CS+
|
inmediatamente después de la intervención
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Angela Fang, PhD, University of Washington
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
26 de junio de 2023
Finalización primaria (Actual)
30 de septiembre de 2024
Finalización del estudio (Actual)
30 de septiembre de 2024
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2023
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2023
Publicado por primera vez (Actual)
1 de agosto de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00013670
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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