CG25Subgenual Cingulate Stimulation in Resistant Depression
Colección de datos
Recopilados desde hoy en adelante - ProspectivoCohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de diciembre de 2007
Fecha en la que se inscribió al primer participante.The protocol involves assessment of effects of CG25 (subgenual cingulate area-Brodmann 25) DBS on mood, anxiety, apathy, anhedonia, psychomotor retardation, functional state as well as safety and tolerance by specific psychometric scores. Moreover the protocol aims at highlighting the neurocircuits modulated by CG25 DBS by means of PET (positron emission tomography) imagery
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 5 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 55 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.Criterios
Inclusion criteria: Men and women between 30 and 55 years old Women at a reproductive age will have to be under successful contraceptive and will undergo a pregnancy test before inclusion Patient suffering from major unipolar depression refractory to conventional therapies Chronic depression with ongoing depressive episode > 12 months. 4 unsuccessful therapies attempted to treat the ongoing episode, including anti-depressant monotherapies, potentialisation of antidepressant treatments, validated structured psychotherapies, electro-convulsive therapy performed accordingly to ANAES ( Agence Nationale d'Accréditation et d'Evaluation en Santé-the French Health Authority) recommendations (at least 6 sessions with bilateral technique and length control of convulsive crisis). Ambulatory or hospital care Able to speak French, understand study procedures and complete questionnaires. Covered by french social health system Living in Rhone-Alpes area without plan to move in the next 2 years Exclusion criteria: History of cerebral surgery Neurological disorder that can interfere with evaluation of surgical procedure or significant cognitive impairment (Mattis score < 30) Psychiatric disorder responsible for comorbidity with the major depressive episode (schizophrenia and other delirium, diagnosed anxiety except generalized anxiety disorder, substance dependency) Personality disorder of A and B clusters Suicidal ideas at evaluation, intention for auto-destruction, repeated suicidal attempts in the last 3 years with emergency care or hospitalization Severe somatic pathology or contraindication to surgery due to heart defibrillator/pacemaker or other implanted device. A decrease superior to or equal to 20% in the 17-Hamilton Depression Rating Scale score between inclusion and pre-surgery evaluation Drug dependency including alcohol in the last 12 months with history of abuse in the last 6 months, with the exception of nicotine Persons protected by the law.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación