Adaptive Design Study of NEST sTMS in Subjects With Major Depressive Disorder
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-011340
NCT ID: NCT03288714
Sponsor Protocol Number: NND-3002
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. Contact the study team to discuss study eligibility and potential participation.
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