Summary

for people ages 22-65 (full criteria)
at UCLA
study started
estimated completion
Andrew Leuchter(ucla)

Description

Summary

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.

Official Title

A Prospective, Multicenter, Double-Blind, Sham-Controlled Adaptive Design Study to Confirm the Safety and Efficacy of NEST sTMS in Subjects With Major Depressive Disorder Who Have Not Responded to at Least One Antidepressant Medication in the Current Episode

Keywords

Depressive Disorder Depression Depressive Disorder, Major Depressive Episode Major Depressive Disorder Transcranial Magnetic Stimulation TMS sTMS Disease Synchronized Transcranial Magnetic Stimulation (sTMS)

Eligibility

You can join if…

Open to people ages 22-65

  • 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)

You CAN'T join if...

  • 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

Locations

  • UCLA Westwood - Semel Institute for Neuroscience and Human Behavior
    Los Angeles California 90024 United States
  • Kadima Neuropsychiatry Institute
    La Jolla California 92037 United States

Lead Scientist

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NeoSync, Inc.
ID
NCT03288714
Study Type
Interventional
Last Updated