Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Completed · Not applicable · Has a placebo group
Conditions studied: Depressive Disorder, Depression, Depressive Disorder, Major, Depressive Episode, Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT03288714
- Run by
- Wave Neuroscience
- People needed
- 121
- Starts
- 2017-11-27
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2021-09-05
Who can join
Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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
Where it is running
- Kadima Neuropsychiatry Institute — La Jolla, California, United States
- UCLA Westwood - Semel Institute for Neuroscience and Human Behavior — Los Angeles, California, United States
- Stanford University — Stanford, California, United States
- Emory University — Atlanta, Georgia, United States
- Sheppard Pratt Health System — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Washington University/Barnes Jewish Hospital — St Louis, Missouri, United States
- New York University — New York, New York, United States
- Laureate Institute for Brain Research — Tulsa, Oklahoma, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Butler Hospital — Providence, Rhode Island, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Brain Health Consultants — Houston, Texas, United States
Full record on ClinicalTrials.gov
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