N/A
N=11
Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder
MDD
Bottom Line
View on ClinicalTrials.gov: NCT04076644 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) — 5; 6.71; 8.14; 9.14 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TMS treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) |
5; 6.71; 8.14; 9.14; 6.14; 7.57 | — |
| PRIMARY Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores |
4.14; 7.57; 8.86; 8.43; 6.86; 8.86 | — |
| PRIMARY Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores |
4.14; 6.29; 6; 5.43; 4.55; 6.14 | — |
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 University of Missouri-Columbia Neuromodulation Clinic. TMS therapy will be given to subjects at monthly intervals. Depression severity questionnaires will be given monthly to determine if the subjects original response to TMS can be maintained. Subjects will be tapered down from antidepressant medication prior to TMS maintenance treatment. Results will be analyzed to determine the effectiveness and feasibility of maintenance TMS therapies in a clinical setting.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- - 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
Data sourced from ClinicalTrials.gov (NCT04076644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.