Clinical trial NCT04076644: Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder
Official title: Maintenance of Response To Transcranial Magnetic Stimulation (TMS) in Major Depressive Disorder (MDD) Using Monthly TMS Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MDD
Keywords: TMS
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 symptoms after having had an acute clinical course of TMS. All potential subjects must have been treated at the University of Missouri Columbia Neuromodulation Clinic to qualify.

There are 2 arms in this study. The first is a group of patients who will not receive any TMS treatments and will be followed for a year, and have their depression severity assessed monthly using the Personal Health Questionnaire (PHQ9), and the Quick Inventory of Depressive Symptoms.

The second arm will receive TMS treatments 5 times/month for 12 months, be assessed for changes in depressive symptom severity monthly using the PHQ9 and QIDS. TMS treatment protocols will consist of wither the standard 20min 10Hz protocol, or a 3min theta-burst protocol. The protocol used will be determined by what worked for the subject when they were treated clinically at the University of Missouri Columbia Neuromodulation clinic. Subjects in this arm will be tapered of antidepressant medication prior to monthly TMS treatment and will remain antidepressant free for the duration of the study.

The study will be a year long in duration.

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

Primary outcomes:
measure: Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
timeFrame: given at monthly intervals for 12 months
measure: Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores
timeFrame: given at baseline and before and after TMS treatment block for 12 months
measure: Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores
timeFrame: given at baseline and before and after each TMS treatment block for 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Neuromodulation Center
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Muaid Ithman, MD
role: PRINCIPAL_INVESTIGATOR
References: