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Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)

NCT04080778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-03

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Conditions

Interventions

DEVICE

magnetic seizure therapy (MST)

MST will be performed with the MagPro XP (120 V) device under anesthesia 2-3 times a week up to 15 sessions.Treatment is performed by magnetic stimulation of both hemispheres inducing a focal stimulation above vertex, using a serial of pulse trains with a frequency of at least 25 Hz but up to 100 Hz for 4-6 s (up to 10 s), which is sufficient to induce a tonic clonic seizure.

DEVICE

electroconvulsive therapy (ECT)

ECT will be performed with MECTA 5000Q, 4th generation ECT devices provided by MECTA Corporation under anesthesia 2-3 times a week up to 15 sessions. For initial procedure Seizure Threshold (ST) will be estimated by empiric titration in the first session of each participant. ST will be then determined as by the manufacturer of ECT Device by the titration schedule for the initial titration session. The subsequent treatment sessions were dosed at 6 times the charge of the seizure threshold.

Sponsors & Collaborators

  • Joao L. DeQuevedo

    lead OTHER

Principal Investigators

  • Joao L. De Quevedo, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-24
Primary Completion
2027-12-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080778 on ClinicalTrials.gov