Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

Part of paid clinical trials in San Diego, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03191058
Status
Completed

Conditions

  • Depression
  • Treatment Resistant Depression
  • Unipolar Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Seizure Therapy — DEVICE
    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.
  • Electroconvulsive Therapy — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jun 26, 2018
Status verified
Apr 2026
Primary completion
Nov 22, 2024
Completion
Nov 22, 2024

Study Design

Enrollment
239 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Magnetic Seizure Therapy (MST)
    MST treatments will be administered using the MagPro MST with Cool TwinCoil.
  • Active Comparator: Electroconvulsive Therapy (ECT)
    ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.

Primary Outcome Measure

Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24) [ Time Frame: Approximately 7 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of California San DiegoSan DiegoCalifornia92127-
University of Texas Southwestern Medical CenterDallasTexas75390-9127-

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California San Diego· San Diego, CAUniversity of Texas Southwestern Medical Center· Dallas, TX

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