Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder

NCT04076644 | Completed Results FDA Device

• 1 other identifier: 2013884
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

MDD

Keywords

TMS

Outcome Measures

Primary Outcomes (3)

• Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)

  The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block, scale is 0-27 with 0=no depression, 27=severe depression

  given at monthly intervals for 12 months

• Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores

  The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression

  given at baseline and before and after TMS treatment block for 12 months

• Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores

  The scale was given at the prior to study starting TMS treatments for the study as a baseline measurement. It was then given prior to every monthly TMS treatment block (Pre Trt Month) and after every monthly TMS treatment block (Post Trt Month) ,scale is 0-27 with 0=no depression, 27=severe depression

  given at baseline and before and after each TMS treatment block for 12 months

Study Arms (2)

TMS Treatment Arm

ACTIVE COMPARATOR

Subjects will receive either a 20min 10hz TMS treatment, or a 3min theta-burst TMS treatment at certain monthly intervals. The TMS treatment protocol they receive depends on what they received in their acute clinical treatment. Subjects in the arm will be tapered off antidepressant medication before TMS treatment begins. Subjects will be assessed monthly for depression using QIDS and PHQ9.

Device: TMS treatment

No TMS Arm

NO INTERVENTION

Subjects will be followed and assessed for depressive symptoms at monthly time intervals similar to the active treatment arm using QIDS and PHQ9. This group does not receive TMS treatment.

Interventions

TMS treatment DEVICE

TMS using either a standard 10hz 20min or 3 min theta burst protocol

Also known as: Transcranial Magnetic Stimulation

TMS Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Neuromodulation Center

Columbia, Missouri, 65203, United States

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Due to changes in staff and start of COVID our recruitment was limited. Orginally a non-TMS treatment arm was planned but due to COVID we were unable to recruit for this arm.

Results Point of Contact

• Title: Matt Schmidt
• Organization: University of Missouri

schmidtmw@health.missouri.edu

573-882-5688

Study Officials

• Muaid Ithman, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: September 3, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 4, 2023
• Results First Posted: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)