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Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder

Overview

Información sobre este estudio

This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Current episode of Major Depressive Disorder
  • Inadequate response to at least one antidepressant medication in the current episode (Treatment Resistant Depression)
  • Investigator able to identify IAF using EEG
  • Willingness and ability to adhere to treatment schedule (5 treatments per week for six weeks)

Exclusion Criteria:

  • Unable to unwilling to give informed consent
  • Diagnosed with excluded conditions or treatment histories
  • Currently hospitalized due to severity of depression symptoms
  • Use of prohibited medications (as defined by protocol) within specified time frame of randomization
  • Use of certain cardiac devices
  • Use of certain intracranial devices
  • Currently pregnant or unwilling to practice acceptable means of birth control, and women who are breastfeeding

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Paul Croarkin, D.O., M.S.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20411295

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