Status:
COMPLETED
Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder
Lead Sponsor:
University of Missouri-Columbia
Conditions:
MDD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This an open label study using a FDA-cleared TMS stimulation protocols which will be used to treat patients who have responded or remitted from depression using acute clinical TMS therapy at the Unive...
Detailed Description
This an open label study using Transcranial Magnetic Stimulation (TMS) as a maintenance treatment for subjects that have seen a clinically significant response or remission from their depressive sympt...
Eligibility Criteria
Inclusion
- Must have recently (within 4 weeks) completed an acute TMS course (full 36 treatments) at the University of Missouri Columbia Neuromodulation clinic
- Must have clinically responded to the acute TMS treatment course (≥50% improvement according to the clinical depressive scale used - usually the PHQ-9)
- Must be able sign consent
- Must have a current address and phone number
- Must have current mental health care provider, either psychiatrist or general practioner who they see for mental health symptom management
- Must be able to taper off antidepressant medication before 1st monthly treatment block (treatment group only)
Exclusion
- \- Subject that has not completed a full acute treatment course, including taper
- Subjects that have changed anything that may not make them safe for TMS, which are (all changes will be reviewed by study MD, and will not necessarily be excluded possibly depending on severity):
- Any new metal near head
- Any new medical devices that cannot be removed
- Any new pregnancies (verbally confirmed)
- Seizures that occurred post-acute TMS treatment
- Any uncontrolled cardiovascular disease
- Any new head trauma
- Any new illness causing injury to brain
- Any new medications which cannot be altered or lowered that may be contraindicated for TMS treatment
- Any drug or alcohol use deemed by the study doctor as unsafe for TMS treatment
- Subjects unwilling to sign consent or follow study procedures
- Subjects with known extended travel plans which may affect study procedures and scheduled TMS treatment
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04076644
Start Date
September 1 2019
End Date
September 1 2021
Last Update
January 4 2023
Active Locations (1)
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1
University of Missouri Neuromodulation Center
Columbia, Missouri, United States, 65203