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Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder

Primary Purpose

MDD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS treatment
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD focused on measuring TMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri Neuromodulation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TMS Treatment Arm

No TMS Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2019
Last Updated
December 8, 2022
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04076644
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD
Keywords
TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS Treatment Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No TMS Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TMS treatment
Other Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
TMS using either a standard 10hz 20min or 3 min theta burst protocol
Primary Outcome Measure Information:
Title
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Description
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
Time Frame
given at monthly intervals for 12 months
Title
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores
Description
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
Time Frame
given at baseline and before and after TMS treatment block for 12 months
Title
Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores
Description
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
Time Frame
given at baseline and before and after each TMS treatment block for 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muaid Ithman, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Neuromodulation Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder

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