Trial Outcomes & Findings for Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder (NCT NCT04076644)
NCT ID: NCT04076644
Last Updated: 2023-01-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
given at monthly intervals for 12 months
Results posted on
2023-01-04
Participant Flow
Dates of recruitment were from 8/14/2019 to 5/21/2021. Participants were recruited from outpatient interventional psychiatry clinic at University of Missouri
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.
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintenance Transcranial Magnetic Stimulation in Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
TMS Treatment Arm
n=10 Participants
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
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|---|---|
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Age, Continuous
|
51 years
STANDARD_DEVIATION 16.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: given at monthly intervals for 12 monthsThe 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
Outcome measures
| Measure |
TMS Treatment Arm
n=7 Participants
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
|
|---|---|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Baseline (prior to starting treatment)
|
5 score on a scale
Standard Deviation 4.04
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 1
|
6.71 score on a scale
Standard Deviation 3.05
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 2
|
8.14 score on a scale
Standard Deviation 3.18
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 3
|
9.14 score on a scale
Standard Deviation 4.67
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 4
|
6.14 score on a scale
Standard Deviation 4.22
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 5
|
7.57 score on a scale
Standard Deviation 6.06
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 6
|
5.85 score on a scale
Standard Deviation 3.09
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|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 7
|
5.71 score on a scale
Standard Deviation 3.49
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|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 8
|
5.86 score on a scale
Standard Deviation 4.26
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 9
|
7.71 score on a scale
Standard Deviation 6.12
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 10
|
6.43 score on a scale
Standard Deviation 5.12
|
|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 11
|
7.43 score on a scale
Standard Deviation 5.83
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|
Depression Severity Changes Scored From Patient Health Questionnaire (PHQ9)
Month 12
|
6.86 score on a scale
Standard Deviation 4.55
|
PRIMARY outcome
Timeframe: given at baseline and before and after TMS treatment block for 12 monthsThe 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
Outcome measures
| Measure |
TMS Treatment Arm
n=7 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
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|
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
|
|
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
|
|
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
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|
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 5.90
|
|
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
|
|
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
|
|
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
|
PRIMARY outcome
Timeframe: given at baseline and before and after each TMS treatment block for 12 monthsThe 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
Outcome measures
| Measure |
TMS Treatment Arm
n=7 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 2.60
|
|
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
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|
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
|
|
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
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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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
TMS Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place