Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

NCT03191058 | Completed DMC FDA Device

• 2 other identifiers: STU 032017-0221R01MH112815-01
• Study Type: interventional
• Target: 219
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Depression; Unipolar Depression; Treatment Resistant Depression; Magnetic Seizure Therapy; Suicidal Ideation; Electroconvulsive Therapy

Outcome Measures

Primary Outcomes (2)

• Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24)

  Hamilton Rating Scale for Depression (24-item version): * 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)

  7 weeks

• Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)

  Autobiographical Memory Test: -Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.

  7 weeks

Secondary Outcomes (1)

• Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)

  7 weeks

Study Arms (2)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Device: Magnetic Seizure Therapy

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

ECT treatments will be administered using the MECTA spECTrum 5000Q or the MECTA Sigma devices.

Device: Electroconvulsive Therapy

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.

Also known as: MST

Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy DEVICE

In the ECT arm treatment, the MECTA spectrum 5000Q or the MECTA Sigma 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

Also known as: ECT

Electroconvulsive Therapy (ECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if they:
• have a history of MINI diagnosis of substance dependence or abuse within the past three months;
• have a concomitant major unstable medical illness;
• are pregnant or intend to get pregnant during the study;
• have a MINI diagnosis of any primary psychotic disorder
• 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
• have probable dementia based on study investigator assessment;
• 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;
• 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);
• 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;
• 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;
• are unable to communicate in English fluently enough to complete the neuropsychological tests;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator
• Centre for Addiction and Mental Health: collaborator
• University of California, San Diego: collaborator

Study Sites (3)

University of California San Diego

San Diego, California, 92127, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9127, United States

Location

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (4)

• Daskalakis ZJ, McClintock SM, Hadas I, Kallioniemi E, Zomorrodi R, Throop A, Palmer L, Farzan F, Thorpe KE, Tamminga C, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology. Trials. 2021 Dec 11;22(1):906. doi: 10.1186/s13063-021-05873-7.

  PMID: 34895296 DERIVED

• Daskalakis ZJ, Tamminga C, Throop A, Palmer L, Dimitrova J, Farzan F, Thorpe KE, McClintock SM, Blumberger DM. Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): study protocol for a randomized non-inferiority trial of magnetic seizure therapy versus electroconvulsive therapy. Trials. 2021 Nov 8;22(1):786. doi: 10.1186/s13063-021-05730-7.

  PMID: 34749782 DERIVED

• Regenold WT, Deng ZD, Lisanby SH. Noninvasive neuromodulation of the prefrontal cortex in mental health disorders. Neuropsychopharmacology. 2022 Jan;47(1):361-372. doi: 10.1038/s41386-021-01094-3. Epub 2021 Jul 16.

  PMID: 34272471 DERIVED

• Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.

  PMID: 34131914 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior

Study Officials

• Daniel Blumberger, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be varying and study personnel will be blinded to the randomization block size.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairperson, Department of Psychiatry

Model Details: The study is a randomized, double blind, parallel--group clinical trial with two treatment arms conducted both at the University of Texas Southwestern in Dallas, Texas and at the Temerty Centre for Therapeutic Brain Intervention based at CAMH in Toronto, Canada. Both sites aim to recruit 130 participants each.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: June 26, 2018
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)