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Behavioural Intervention

TMS vs ECT for Depression

N/A

Waitlist Available

Research Sponsored by Austin Messner

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 65 years

Patients treated for TRD who have achieved remission through an index series of ECT

Must not have

History of seizures or a seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and prior to each procedure for duration of study, up to six months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two treatments for long-term management of severe depression. One is electroconvulsive therapy (ECT), which is effective but has drawbacks like cognitive side effects and the need for anesthesia. The

Who is the study for?

This trial is for individuals with treatment-resistant major depressive disorder who have already undergone electroconvulsive therapy (ECT). Participants should prefer and be able to attend outpatient sessions, as they will choose between maintenance Transcranial Magnetic Stimulation (TMS) or continuing ECT.

What is being tested?

The study tests if maintenance TMS can effectively maintain remission in patients with treatment-resistant depression compared to the standard maintenance ECT. It's a patient-preference trial, meaning participants choose their treatment without random assignment.

What are the potential side effects?

Maintenance TMS generally has fewer side effects than ECT, mainly involving mild discomfort at the stimulation site or headache. In contrast, ECT may include cognitive side effects, memory issues, and requires anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been treated for depression with ECT and it worked.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of seizures or a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline on initial presentation, at 6 months, and at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline on initial presentation, at 6 months, and at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline on initial presentation, at 6 months, and at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hamilton Depression Rating Scale (HDRS)

Secondary study objectives

Change in Quick inventory of depressive symptomatology (QIDS)

Change in Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TMSExperimental Treatment1 Intervention

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 II: ECTActive Control1 Intervention

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.

0 / 3Eligibility criteria met