Trial Outcomes & Findings for Maintenance TMS in Treatment Resistant Depression (NCT NCT06682299)
NCT ID: NCT06682299
Last Updated: 2026-05-12
Results Overview
One of the most widely used clinician administered depression scales containing 17 items. Scores range from 0 to 54 with 0-7 being normal, 8-16 being mild depression, 17-23 moderate depression and 24 or greater being severe depression. Higher scores equate to more severe depressive symptoms.
TERMINATED
NA
1 participants
Baseline and prior to each procedure for duration of study, up to six months
2026-05-12
Participant Flow
Participant milestones
| Measure |
Transcranial Magnetic Stimulation (TMS)
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. They will receive TMS in this arm of study for maintenance treatment of their depression and monitored with depressive scales.
Transmagnetic Stimulation: TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments).
|
Electroconvulsive Therapy (ECT)
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. If they elect to continue with maintenance ECT treatments which is the current standard of care, their depressive symptoms and cognitive functioning will be monitored accordingly.
Electroconvulsive Therapy: Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression
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|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maintenance TMS in Treatment Resistant Depression
Baseline characteristics by cohort
| Measure |
Transcranial Magnetic Stimulation (TMS)
n=1 Participants
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. They will receive TMS in this arm of study for maintenance treatment of their depression and monitored with depressive scales.
Transmagnetic Stimulation: TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments).
|
Electroconvulsive Therapy (ECT)
Patients who have achieved remission of treatment resistant depression through an initial course of ECT (8 to 12 sessions) at the University of Kentucky will be identified by the ECT attending physician as a candidate for this study. If they elect to continue with maintenance ECT treatments which is the current standard of care, their depressive symptoms and cognitive functioning will be monitored accordingly.
Electroconvulsive Therapy: Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=1512 Participants
|
—
|
1 participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: Baseline and prior to each procedure for duration of study, up to six monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
One of the most widely used clinician administered depression scales containing 17 items. Scores range from 0 to 54 with 0-7 being normal, 8-16 being mild depression, 17-23 moderate depression and 24 or greater being severe depression. Higher scores equate to more severe depressive symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and prior to each procedure for duration of study, up to six monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
A widely used self-report scale of depression with similar validity to the HDRS that consists of 16 scale items. Scores range from 0 to 27 with 0-5 indicating no depression, 6-10 mild depression, 11-15 moderate depression, 16-20 severe, and 21 or higher very severe. Higher scores equate to more severe depressive symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline on initial presentation, at 6 months, and at 12 monthsPopulation: One participant was enrolled in this study. Due to the possibility that participants could reasonably be identified due to low enrollment, data cannot be presented.
Cognitive screening tool that is individually administered battery to measure cognitive decline or improvement. Scores range from 40 to 160. 69 and below is extremely low, 70-79 borderline, 80-89 low average, 90-109 average, 110-119 high average, 12-129 superior, and 130+ very superior. Higher scores equate to better cognitive functioning.
Outcome measures
Outcome data not reported
Adverse Events
Transcranial Magnetic Stimulation (TMS)
Electroconvulsive Therapy (ECT)
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