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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20411295

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