Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST)

April 17, 2026 updated by: Carol A. Tamminga, University of Texas Southwestern Medical Center

Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST - MST)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will involve a randomized, double blind, non-inferiority clinical trial with two treatment arms conducted in two international academic medical centers (the Centre for Addiction and Mental Health in Toronto, Canada and UT Southwestern in Dallas, Texas). The investigators are pursuing a non-inferiority clinical trial in an effort to compare MST - a new treatment for TRD - to RUL-UB-ECT. Treatment will be administered two to three days per week. Depression symptoms will be assessed with the 24-item Hamilton Depression Rating Scale (HRSD-24) and suicidality will be assessed with the Scale for Suicidal Ideation (SSI). Remission will be defined as HRSD-24 < or = 10 and a > 60% decrease in scores from baseline on two consecutive ratings. Once a participant reaches remission, a second rating to confirm remission will be conducted immediately before their next scheduled treatment. If remission is confirmed, they will then be considered a completer of the acute treatment course. Remission of suicidal ideation is defined as a score of 0 on the SSI. Therefore, there will be no specific minimum number of treatments that patients must receive to be classified as remitters. However, patients who do not meet remission criteria after 21 treatment sessions will be considered non-remitters and will cease treatment sessions. This maximum treatment number was chosen allowing for the possibility that MST may require more treatment sessions to achieve remission, similar to RUL-UB ECT. The blind will not be broken to participants until the completion of the entire study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
  • United States
    • California
      • San Diego, California, United States, 92127
        • University of California San Diego
    • Texas
      • Dallas, Texas, United States, 75390-9127
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Patients will be included if they:

  1. are inpatients or outpatients;
  2. are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
  3. have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
  4. are 18 years of age or older
  5. have a baseline HRSD-24 score > or = 21;
  6. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
  7. are agreeable to keeping their current antidepressant treatment constant during the intervention;
  8. are likely able to adhere to the intervention schedule;
  9. meet the MST safety criteria [75];
  10. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

Exclusion Criteria

Patients will be excluded if they:

  1. have a history of MINI diagnosis of substance dependence or abuse within the past three months;
  2. have a concomitant major unstable medical illness;
  3. are pregnant or intend to get pregnant during the study;
  4. have a MINI diagnosis of any primary psychotic disorder
  5. have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
  6. have probable dementia based on study investigator assessment;
  7. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
  8. present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
  9. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  10. require a benzodiazepine with a dose > lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
  11. are unable to communicate in English fluently enough to complete the neuropsychological tests;
  12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Magnetic Seizure Therapy (MST)
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
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.

Other Names:
  • MST
Active Comparator: Electroconvulsive Therapy (ECT)
ECT treatments will be administered using the MECTA spECTrum 5000Q or the Sigmastim devices.
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
Other Names:
  • ECT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Remission of Depression on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)
Time Frame: Approximately 7 weeks

This scale is used to quantify the severity of symptoms of depression

  • Scale range: 0-76 (total score)
  • Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
  • Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Remission defined as a HRSD-24 total score of ≤10 and 60% reduction from baseline on two consecutive assessments.

The outcome is reported as number of participants meeting remission criteria in each treatment group.
Approximately 7 weeks
Worsening of Autobiographical Memory on the Autobiographical Memory Test (AMT)
Time Frame: Approximately 7 weeks

In the Autobiographical Memory Test (AMT), participants are presented with emotional cue words and asked to retrieve a personal memory within a brief response window; interview formats have been shown to produce fewer specific and more overgeneral memories.

The outcome is reported as the number of participants who meet the predefined worsening criterion at follow-up.

The binary outcome was defined as a worsening from baseline of >25% on the AMT total score.
Approximately 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Remission on the Scale for Suicidal Ideation (SSI)
Time Frame: Approximately 7 weeks

Remission of suicidal ideation will be assessed using the Scale for Suicidal Ideation (SSI), a clinician-administered tool with 19 scored items rated 0-2, total score range 0-38. Higher scores indicate greater suicidal ideation severity.

Remission is defined as an SSI total score of 0 at follow-up. The outcome is the number of participants who meet remission criteria compared with baseline.
Approximately 7 weeks
Response on the Hamilton Rating Scale for Depression-24 Item (HRSD-24)
Time Frame: Approximately 7 weeks

This scale is used to quantify the severity of symptoms of depression

  • Scale range: 0-76 (total score)
  • Lower scores indicate lower severity of depressive symptoms (i.e., better outcome)
  • Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome) Response is defined as a HRSD-24 reduction of 50% or greater from baseline The outcome is reported as number of participants meeting response criteria in each treatment group.
Approximately 7 weeks
Score on the Brief Symptom Inventory Anxiety Section (BSI-A)
Time Frame: Approximately 7 weeks

The Brief Symptom Inventory (BSI) anxiety section (ANX) is a subscale comprised of 6 items designed to measure subjective experiences of tension, panic, and restlessness over the past week. It uses a 5-point Likert scale (0=not at all to 4=extremely) to identify symptoms like "nervousness," "feeling tense," or "spells of terror".

Higher = worse; lower = better. The total score ranges from 0 to 24.
Approximately 7 weeks
Response on the Clinical Global Impression - Improvement Scale (CGI-I)
Time Frame: Approximately 7 weeks

The Clinical Global Impression-Improvement (CGI-I) scale is a 7-point, observer-rated tool used to measure how much a patient's illness has improved or worsened relative to their baseline. It is rated from 1 (very much improved) to 7 (very much worse).

Response is defined as a CGI-I score of 1 or 2.
Approximately 7 weeks
Score on the Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame: Approximately 7 weeks
The Q-LES-Q-SF (Short Form) measures quality of life through 14 items, each rated on a 1-5 scale (1=Very Poor, 5=Very Good). Total raw scores range from 14 to 70, with higher scores indicating greater satisfaction.
Approximately 7 weeks
Score on the Columbia ECT Subjective Side Effects Schedule (CSSES)
Time Frame: Approximately 7 weeks

The Columbia ECT Subjective Side Effects Schedule is a tool used to monitor adverse effects after each ECT session and at baseline. It tracks physical, cognitive, and mood side effects.

For the physical scale (range 0-15) and cognitive scale (range 0-6) it uses a 4-point Likert-type scale where 0 = none; 1 = yes, mild; 2 = yes, moderate; and 3 = yes, severe.

For the mood scale (range 0-3) it uses a 2-point Likert-type scale where 0 = no; 1 = yes.

For the physical and cognitive scales, higher values indicate a worse outcome. For the mood scale, higher values indicate a better outcome.
Approximately 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
University of California, San Diego
Centre for Addiction and Mental Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel Blumberger, MD, Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 032017-022
  • 1R01MH112815-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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