Oxytocin, Trauma Disclosure and Intrusions
1 de febrero de 2018 actualizado por: Rene Hurlemann, University Hospital, Bonn
Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects.
Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions.
In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD).
Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects.
Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder.
However, the underlying neurobiological mechanisms are unclear.
Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience.
Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.
Descripción general del estudio
Descripción detallada
Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study.
After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1.
OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days).
The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).
Tipo de estudio
Intervencionista
Inscripción (Actual)
70
Fase
- Fase 1
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
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Bonn, Alemania, 53105
- Department of Psychiatry, University of Bonn
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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
18 años a 40 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Healthy female volunteers
- Right-handed
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Hormonal contraception
- MRI contraindication (e.g. metal in body, claustrophobia)
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Oxytocin (6 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day)
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Intranasal administration, 24 international units (IU) oxytocin.
Otros nombres:
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Comparador activo: Oxytocin (3 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure
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Intranasal administration, 24 international units (IU) oxytocin.
Otros nombres:
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Comparador de placebos: Placebo
Placebo nasal spray for six days
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Los aerosoles nasales de placebo contienen ingredientes idénticos excepto por el péptido en sí.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Total number of intrusions following the first trauma movie exposure.
Periodo de tiempo: Three days following the first trauma movie exposure.
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The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
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Three days following the first trauma movie exposure.
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Total number of intrusions following the second trauma movie exposure.
Periodo de tiempo: Three days following the second trauma movie exposure.
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The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
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Three days following the second trauma movie exposure.
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Neural responses to emotional faces in the amygdala.
Periodo de tiempo: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli.
The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
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Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Neural responses to emotional faces in the prefrontal cortex.
Periodo de tiempo: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli.
The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
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Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
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fMRI resting state data
Periodo de tiempo: Functional data will be acquired for 6 min.
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Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular.
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Functional data will be acquired for 6 min.
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Trauma disclosure (time spend discussing the movie)
Periodo de tiempo: Six days following the first trauma movie exposure.
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The intrusion diaries will contain a question for how long participants discussed the trauma movie.
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Six days following the first trauma movie exposure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in pupil diameter in response to the trauma movie
Periodo de tiempo: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in pupil diameter will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in skin conductance level in response to the trauma movie
Periodo de tiempo: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in skin conductance level will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in respiration rate in response to the trauma movie
Periodo de tiempo: 2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Changes in respiration rate will be measured.
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2 min baseline before the trauma movie and during 15 min of the trauma movie.
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Salivary oxytocin concentrations
Periodo de tiempo: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Saliva samples will be collected before and after the trauma movie to assess changes in oxytocin concentrations.
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Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Salivary cortisol concentrations
Periodo de tiempo: Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Saliva samples will be collected before and after the trauma movie to assess changes in cortisol concentrations.
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Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.
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Questionnaire measurement of mood (PANAS)
Periodo de tiempo: 10 min before and 10 min after the trauma movie.
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Positive and negative affect will be assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
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10 min before and 10 min after the trauma movie.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: René Hurlemann, MD, PhD, University of Bonn
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
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)
1 de junio de 2016
Finalización primaria (Actual)
18 de marzo de 2017
Finalización del estudio (Actual)
18 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
28 de enero de 2018
Primero enviado que cumplió con los criterios de control de calidad
1 de febrero de 2018
Publicado por primera vez (Actual)
8 de febrero de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de febrero de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
1 de febrero de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PROXY
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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