Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

Summary

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.

Conditions

• Depression
• Unipolar Depression
• Treatment Resistant Depression

Interventions

DEVICE

Magnetic Seizure Therapy

MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds). This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.

DEVICE

Electroconvulsive Therapy

In the ECT arm treatment, the MECTA spectrum 5000Q or the Sigmastim devices will be used, which are FDA approved devices used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Centre for Addiction and Mental Health

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Daniel Blumberger, MD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-26

Primary Completion

2024-11-22

Completion

2024-11-22

FDA Device

Yes

Countries

• United States
• Canada

Study Locations