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Neurocardiac Control in Major Depression

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Qué se está recopilando

Colección de datos

Quiénes están siendo reclutados

Trastorno depresivo

+ Trastornos Mentales

+ Trastorno Depresivo Mayor

De 18 a 50 años
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Cómo está diseñado el estudio

Observacional
Inicio del estudio: marzo de 2004
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Resumen

Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 30 de marzo de 2004

Fecha en la que se inscribió al primer participante.

The presence of major depression, with or without pre-existing coronary artery disease, predicts increased mortality from myocardial infarction (MI) and sudden cardiac death (SCD). Decreased parasympathetic vagal outflow, especially in the presence of elevated cardiac sympathetic tone, has been proposed as a mechanism for the increased risk of SCD. Multiple lines of evidence suggests that fronto-limbic areas are actively engaged in the robust optimization of autonomic balance between sympathetic and parasympathetic cardiac outflow over a broad range of cognitive and physical demands. We propose that dysfunction of these forebrain neurocardiac networks in MDD mediates maladaptive cardiac autonomic control and the increased risk of cardiovascular mortality. In this model, neurocardiac control networks exhibit a systemic bias toward increased sympathetic relative to parasympathetic outflow. Increased amygdalar activity in MDD will promote this imbalance. Additionally, dysfunction in posterior orbitofrontal cortex (OFC) and ventral anterior cingulated cortex (ACC), areas associated with abnormal histopathological changes in MDD, will lead to reduced capacity for generating adaptive levels of cardioinhibitory, parasympathetic tone. This reduced capacity in depressives will be evidenced by abnormally large withdrawals of parasympathetic outflow, compared to healthy controls, as cognitive or physical demands increase. This dynamic model is potentially consistent with functional neuroimaging and post mortem histopathological findings in MDD and the knowledge gained through testing this protocol may ultimately elucidate how brain dysfunction in MDD mediates significantly increased clinical risk of spontaneous ventricular arrhythmias and sudden cardiac death. We propose to combine H (2) (15) O positron emission tomography (PET) and analysis of heart rate variability (HRV) in order to study in vivo the neural structures underlying normal forebrain control of cardiac autonomic function. We further aim to show whether regional functional abnormalities in amygdala, ventral anterior cingulate cortex, and orbitofrontal cortex-areas in which functional abnormalities have been identified in previous neuroimaging studies of major depressives-are associated with impaired modulation of cardiac autonomic function during major depression.

Título OficialNeurocardiac Control in Major Depression 
NCT00084162
Patrocinador PrincipalNational Institute of Mental Health (NIMH)
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 41 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 50 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Trastorno depresivoTrastornos MentalesTrastorno Depresivo Mayor

Criterios

* INCLUSION CRITERIA: Two groups of right-handed subjects, male or premenopausal female, who are drug-naive or who have not received psychotropic drugs for at least 3 weeks (8 weeks for fluoxetine), will be recruited for studies under this protocol: unipolar depressives and healthy controls individually matched to depressives by age, gender and smoking status. Because effective treatment will not be discontinued for the purposes of this protocol, subjects in the patient groups will be identified who have never been treated for or who have discontinued medication due to lack of efficacy, noncompliance, physician order or other reason prior to study entry. The presence of inclusion and exclusion criteria will be established using both an unstructured clinical interview with a psychiatrist and the Structure Clinical Interview for DSM-IV (SCID). Family history of mental illness will be obtained using the Family Interview of Genetic Studies. EXCLUSION CRITERIA: Subjects will be excluded if they have: serious suicidal ideation or behavior; inability to provide informed consent; medical or neurological illnesses likely to affect physiology or anatomy; a history of drug or alcohol abuse within 1 year or a lifetime history of alcohol or drug dependence (DSM-IV criteria); current or past history of other axis I disorders that preceded the onset of MDD; current pregnancy (documented by pregnancy testing prior to scanning); current breast feeding; general MRI exclusion criteria; vision and/or hearing problems severe enough to interfere with testing. Exposure within two weeks to medications likely to affect cerebral blood glow or heart rate. Any condition that may prevent the subject from performing the run/walk test, or Irregular menstrual cycles so that menstrual phase cannot be reliably determined, or Any ECG finding that would contraindicate PET scanning or run/walk testing (e.g. non-sinus rhythm, significant tachycardia, ST segment elevation or depression, Q waves) or arrhythmia that would obviate accurate calculation of HRV indices. Cardiology consultation will be obtained for abnormal ECG findings unless it is unequivocally clear in the judgment of the study physician that such consultation is medically unnecessary. Subjects who are beyond age 50 who are either postmenopausal or perimenopausal are excluded to reduce the biological heterogeneity in autonomic function which may be associated with difference in menstrual status.

Centros del Estudio

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Este estudio tiene una ubicación

Suspendido

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesVer ubicación
Completado1 Centros de Estudio