Not provided
Not provided
Not provided
Not provided
Not provided
Lack of enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Electroconvulsive therapy (ECT) is one of the most efficacious treatments available for treatment-resistant depression (TRD). Although a maintenance ECT protocol exists, multiple barriers limit its use for long-term use. These barriers include procedure tolerability, cognitive side effects, financial burden, and unreliable social support to accompany patients for these treatments. On the other hand, a different modality of noninvasive neuromodulation called transcranial magnetic stimulation (TMS) can be performed in the outpatient setting and does not need anesthesia. The likelihood of cognitive adverse effects with TMS is much lower than with ECT. Our clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder.
This will be a patient-preference clinical trial, with patients offered the choice to initiate maintenance TMS versus maintenance ECT after their index ECT sessions for treatment-resistant depression. There will be no randomization or placebo involved in this study.
The clinical question encompasses piloting a maintenance TMS regimen to maintain remission in treatment-resistant major depressive disorder.
Patients who choose maintenance TMS will initiate maintenance TMS sessions on day one of the study and continue any currently prescribed pharmacotherapy. Participants will initiate TMS treatment within 1 week of last index ECT treatment. Participants will then follow a schedule of weekly for 4 sessions, every other week for 4 sessions, and monthly for 3 sessions for a total of 11 sessions in 6 months. Investigators will use the TMS paradigm called intermittent theta burst stimulation (iTBS), which was used in the SNT trial(Cole et al., 2022; Cole et al., 2020). At conclusion of the 6 month TMS portion of the study clinical judgement will be used to determine if the patient will return to maintenance ECT treatment. RBANS for assessment of cognition will be completed at the beginning, after 6 months, and at the conclusion of the study as well in both the standard of care and TMS portions of the study.
Those who choose maintenance ECT will transition to maintenance ECT treatments in the hospital as prescribed by their treating inpatient psychiatrists. On initial visit consent will be obtained and baseline cognitive and behavioral scales assessed as follows: Antidepressant treatment history form (ATHF), alcohol use disorder identification test (AUDIT-C), Hamilton Depression Rating Scale (HDRS), Clinical Global Impression (CGI), quick inventory of depressive symptomology (QIDS), Brief Psychiatric Rating Scale (BPRS), Drug Abuse Screening Test (DAST-10), Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS), standardized assessment of personality abbreviated scale (SAPAS). Patients will then be asked to return at 6 month and 12 month intervals to repeat HDRS, QIDS, RBANS, and CGI scales.
Research data will be collected primarily through self assessment scales including Antidepressant treatment history form (ATHF), alcohol use disorder identification test (AUDIT-C), Hamilton Depression Rating Scale (HDRS), Clinical Global Impression (CGI), quick inventory of depressive symptomology (QIDS), Brief Psychiatric Rating Scale (BPRS), Drug Abuse Screening Test (DAST-10), Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS), standardized assessment of personality abbreviated scale (SAPAS).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Experimental | 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. |
|
| ECT | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transmagnetic Stimulation | Device | TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale (HDRS) | 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. | Baseline and prior to each procedure for duration of study, up to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quick Inventory of Depressive Symptomatology (QIDS) | 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. | Baseline and prior to each procedure for duration of study, up to six months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gopalkumar Rakesh, MD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40509 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29077650 | Background | Rachid F. Safety and Efficacy of Theta-Burst Stimulation in the Treatment of Psychiatric Disorders: A Review of the Literature. J Nerv Ment Dis. 2017 Nov;205(11):823-839. doi: 10.1097/NMD.0000000000000742. | |
| 19833552 | Background | Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
0 participants enrolled in the ECT arm
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale (HDRS) | 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. | 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. | Posted | Count of Participants | Participants | Baseline and prior to each procedure for duration of study, up to six months |
|
Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Austin Messner | University of Kentucky | (859) 323-6861 | austin.messner@uky.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 28, 2026 | Apr 15, 2026 | Prot_SAP_ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| D019305 | Epilepsy, Rolandic |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
Open label patient preference trial
Not provided
Not provided
Not provided
Not provided
|
| Electroconvulsive Therapy | Device | Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression |
|
|
| Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) | 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. | Baseline on initial presentation, at 6 months, and at 12 months |
| 34592659 | Background | Wilson S, Croarkin PE, Aaronson ST, Carpenter LL, Cochran M, Stultz DJ, Kozel FA. Systematic review of preservation TMS that includes continuation, maintenance, relapse-prevention, and rescue TMS. J Affect Disord. 2022 Jan 1;296:79-88. doi: 10.1016/j.jad.2021.09.040. Epub 2021 Sep 17. |
| 27536079 | Background | Magnezi R, Aminov E, Shmuel D, Dreifuss M, Dannon P. Comparison between neurostimulation techniques repetitive transcranial magnetic stimulation vs electroconvulsive therapy for the treatment of resistant depression: patient preference and cost-effectiveness. Patient Prefer Adherence. 2016 Aug 4;10:1481-7. doi: 10.2147/PPA.S105654. eCollection 2016. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
| Secondary | Change in Quick Inventory of Depressive Symptomatology (QIDS) | 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. | 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. | Posted | Count of Participants | Participants | Baseline and prior to each procedure for duration of study, up to six months |
|
|
| Secondary | Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS) | 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. | 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. | Posted | Baseline on initial presentation, at 6 months, and at 12 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D001519 |
| Behavior |
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |