MDD
Conditions
Keywords
TMS
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.
Interventions
DEVICETMS treatment
TMS using either a standard 10hz 20min or 3 min theta burst protocol
Sponsors
University of Missouri-Columbia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | given at monthly intervals for 12 months | 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 | given at baseline and before and after TMS treatment block for 12 months | 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 | given at baseline and before and after each TMS treatment block for 12 months | 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 |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment were from 8/14/2019 to 5/21/2021. Participants were recruited from outpatient interventional psychiatry clinic at University of Missouri
Pre-assignment details
Participants had up to 8 weeks to washout of their antidepressant medication, if they could not handle this washout they could not start maintenance treatment. Although two arms were originally planned due to COVID the 2nd arm consisting of group of patients who will not receive any TMS treatments was unable to be recruited.
Participants by arm
| Arm | Count |
|---|---|
| TMS Treatment Arm 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.
TMS treatment: TMS using either a standard 10hz 20min or 3 min theta burst protocol | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | TMS Treatment Arm |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 16.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Time frame: given at monthly intervals for 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Baseline (prior to starting treatment) | 5 score on a scale | Standard Deviation 4.04 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 1 | 6.71 score on a scale | Standard Deviation 3.05 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 2 | 8.14 score on a scale | Standard Deviation 3.18 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 3 | 9.14 score on a scale | Standard Deviation 4.67 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 4 | 6.14 score on a scale | Standard Deviation 4.22 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 5 | 7.57 score on a scale | Standard Deviation 6.06 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 6 | 5.85 score on a scale | Standard Deviation 3.09 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 7 | 5.71 score on a scale | Standard Deviation 3.49 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 8 | 5.86 score on a scale | Standard Deviation 4.26 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 9 | 7.71 score on a scale | Standard Deviation 6.12 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 10 | 6.43 score on a scale | Standard Deviation 5.12 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 11 | 7.43 score on a scale | Standard Deviation 5.83 |
| TMS Treatment Arm | Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9) | Month 12 | 6.86 score on a scale | Standard Deviation 4.55 |
Primary
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
Time frame: given at baseline and before and after each TMS treatment block for 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Baseline | 4.14 score on a scale | Standard Deviation 2.36 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 1 | 6.29 score on a scale | Standard Deviation 2.6 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 2 | 6 score on a scale | Standard Deviation 2.39 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 3 | 5.43 score on a scale | Standard Deviation 2.44 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 4 | 4.55 score on a scale | Standard Deviation 4.06 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 5 | 6.14 score on a scale | Standard Deviation 3.72 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 6 | 4.71 score on a scale | Standard Deviation 3.88 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 7 | 5 score on a scale | Standard Deviation 2.53 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 8 | 5.43 score on a scale | Standard Deviation 3.02 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 9 | 6.57 score on a scale | Standard Deviation 4.56 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 10 | 5 score on a scale | Standard Deviation 4.14 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 11 | 5.57 score on a scale | Standard Deviation 3.42 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Post Treatment Monthly Scores | Post Trt Month 12 | 5.43 score on a scale | Standard Deviation 3.29 |
Primary
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
Time frame: given at baseline and before and after TMS treatment block for 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Baseline | 4.14 score on a scale | Standard Deviation 2.36 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 1 | 7.57 score on a scale | Standard Deviation 3.33 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 2 | 8.86 score on a scale | Standard Deviation 4.09 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 3 | 8.43 score on a scale | Standard Deviation 4.27 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 4 | 6.86 score on a scale | Standard Deviation 4.55 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 5 | 8.86 score on a scale | Standard Deviation 5.67 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 6 | 7 score on a scale | Standard Deviation 6.07 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 7 | 5.43 score on a scale | Standard Deviation 2.82 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 8 | 6.29 score on a scale | Standard Deviation 3.41 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 9 | 8.71 score on a scale | Standard Deviation 5.9 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 10 | 6.86 score on a scale | Standard Deviation 5.17 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 11 | 7.57 score on a scale | Standard Deviation 4.66 |
| TMS Treatment Arm | Depression Severity Changes Scored From Quick Inventory of Depression Symptom Questionnaire (QIDS) Pre Treatment Monthly Scores | Pre Trt Month 12 | 8.71 score on a scale | Standard Deviation 4.91 |