Maintenance TMS in Treatment Resistant Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-17

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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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

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Treatment Resistant Depression (TRD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Open label patient preference trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transmagnetic Stimulation

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy

Intervention Type DEVICE

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

Interventions

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Transmagnetic Stimulation

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

Intervention Type DEVICE

Electroconvulsive Therapy

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

Intervention Type DEVICE

Other Intervention Names

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TMS ECT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No