Status:
COMPLETED
Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Lead Sponsor:
Wave Neuroscience
Conditions:
Depressive Disorder
Depression
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief 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 experien...
Detailed Description
Prospective, randomized, double-blind, sham-controlled, parallel group adaptive design study to confirm the safety and efficacy of sTMS in subject with Major Depressive Disorder (MDD) who have not res...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03288714
Start Date
November 27 2017
End Date
June 1 2019
Last Update
September 5 2021
Active Locations (14)
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1
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
2
UCLA Westwood - Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90024
3
Stanford University
Stanford, California, United States, 94305
4
Emory University
Atlanta, Georgia, United States, 30329