Treatment Resistant Depression (TRD)NCT06682299
Maintenance TMS in Treatment Resistant Depression
A study testing Transmagnetic Stimulation and Electroconvulsive Therapy in people with Treatment Resistant Depression (TRD), run by Austin Messner at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Transmagnetic Stimulation and Electroconvulsive Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated for TRD who have achieved remission through an index series of ECT
- Able to provide informed consent
- Age between 18 and 65 years
- Deemed appropriate for maintenance TMS by their psychiatrist
- Right-handed
Who cannot join
- History of seizures or a seizure disorder
- Related neurological disorder, or any other medical condition that would preclude TMS treatment determined by the treatment team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitioning From Maintenance ECT to Maintenance TMS in Treatment Resistant Depression
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.
Read the detailed description
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).
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Transmagnetic Stimulation, Electroconvulsive Therapy
- Keywords
- depression, tms, ect, treatment resistant depression, trd
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depression, Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmagnetic StimulationDevice
Also called TMS
TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments).
Electroconvulsive TherapyDevice
Also called ECT
Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transmagnetic Stimulation |
| 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. Receives: Device: Electroconvulsive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and prior to each procedure for duration of study, up to six months
Secondary outcomes (2)
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.
Measured: Baseline and prior to each procedure for duration of study, up to six months
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.
Measured: Baseline on initial presentation, at 6 months, and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start17 Apr 2025
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant Depression (TRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open label patient preference trial
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Messner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Austin Messner, University of Kentucky
- Investigators
- Gopalkumar Rakesh, MD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682299
- Sponsor's protocol ID
- 95789
- Status last verified
- May 2026
- First submitted
- 7 Nov 2024
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29077650Rossi 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.
PubMed 19833552Wilson 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.
PubMed 34592659Magnezi 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.
PubMed 27536079
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning From Maintenance ECT to Maintenance TMS in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT06682299
- Acronym / sponsor ID
- 95789
- Conditions
- Treatment Resistant Depression (TRD)
- Keywords
- depression, tms, ect, treatment resistant depression, trd
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Austin MessnerUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label patient preference trial
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Transmagnetic StimulationPatients 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 | Device: Electroconvulsive TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients treated for TRD who have achieved remission through an index series of ECT
- Able to provide informed consent
- Age between 18 and 65 years
- Deemed appropriate for maintenance TMS by their psychiatrist
- Right-handed
Key exclusion criteria (2 listed)
- History of seizures or a seizure disorder
- Related neurological disorder, or any other medical condition that would preclude TMS treatment determined by the treatment team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmagnetic StimulationAlso: TMSTMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments). | Device | TMS |
| Electroconvulsive TherapyAlso: ECTPatients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression | Device | ECT |
Primary outcome
Change in Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline and prior to each procedure for duration of study, up to six months
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.
2 secondary outcomes
Change in Quick Inventory of Depressive Symptomatology (QIDS)
Time frame: Baseline and prior to each procedure for duration of study, up to six months
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)
Time frame: Baseline on initial presentation, at 6 months, and at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29077650Rachid 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.
- Background: PubMed 19833552Rossi 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.
- Background: PubMed 34592659Wilson 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.
- Background: PubMed 27536079Magnezi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopalkumar Rakesh, MD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmagnetic Stimulation and Electroconvulsive Therapy in people with Treatment Resistant Depression (TRD), run by Austin Messner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hamilton Depression Rating Scale (HDRS) (time frame: Baseline and prior to each procedure for duration of study, up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682299, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.