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Maintenance TMS in Treatment Resistant Depression

Transitioning From Maintenance ECT to Maintenance TMS in Treatment Resistant Depression

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06682299
Enrollment
1
Registered
2024-11-12
Start date
2025-04-17
Completion date
2025-06-26
Last updated
2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression (TRD)

Keywords

depression, tms, ect, treatment resistant depression, trd

Brief 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. 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).

Interventions

TMS will be given for the maintenance treatment of treatment resistant depression following successful course of ECT (8-12 treatments).

DEVICEElectroconvulsive Therapy

Patients will remain in standard of care treatment and receive maintenance ECT treatments for treatment resistant depression

Sponsors

Austin Messner
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Open label patient preference trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Hamilton Depression Rating Scale (HDRS)Baseline and prior to each procedure for duration of study, up to six monthsOne 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.

Secondary

MeasureTime frameDescription
Change in Quick Inventory of Depressive Symptomatology (QIDS)Baseline and prior to each procedure for duration of study, up to six monthsA 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.
Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)Baseline on initial presentation, at 6 months, and at 12 monthsCognitive 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.

Countries

United States

Contacts

STUDY_DIRECTORGopalkumar Rakesh, MD

University of Kentucky

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
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
0 Participants
Race (NIH/OMB)
White
1 Participants
Region of Enrollment
United States
1 participants
Sex: Female, Male
Female
1 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026