Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression

Not Applicable

Completed

• Conditions: Unipolar Depression; Depression; Treatment Resistant Depression
• Interventions: Device: Electroconvulsive Therapy; Device: Magnetic Seizure Therapy

• Registration Number: NCT03191058
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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 Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2018-06-26
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electroconvulsive Therapy (ECT)	Electroconvulsive Therapy	ECT treatments will be administered using the MECTA spECTrum 5000Q or the MECTA Sigma devices.
Magnetic Seizure Therapy (MST)	Magnetic Seizure Therapy	MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Primary Outcome Measures

Name	Time	Method
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24)	7 weeks	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)
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)	7 weeks	Autobiographical Memory Test: -Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.

Secondary Outcome Measures

Name	Time	Method
Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)	7 weeks	Scale for Suicidal Ideation: * This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas; * Scale range: 0 - 38 (total score); * Lower scores indicate lower severity of suicidal ideation (i.e., better outcome); * Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

Trial Locations

Locations (3)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada