Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder

Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder

This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Electroconvulsive Therapy (n=30); Device: Magnetic Seizure Therapy (n=30)

Detailed Description

Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response.

Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ability to consent
2. Clinically indicated for seizure therapy
3. Patients with MDD who had either never received antidepressant treatment or had discontinued antidepressants by their own choice for at least six weeks prior to enrollment (as commonly done in routine clinical care in this jurisdiction due to more negative views of psychotropics)
4. 18-65 years of age.

Exclusion Criteria:

1. Dementia,
2. Delirium
3. History of significant head trauma
4. Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
5. Substance dependence
6. Active comorbidity with another psychiatric disorder
7. Patients who had previously received ECT or TMS
8. Current unstable or serious medical illness (e.g., myocardial infarction)
9. Pregnancy
10. Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
11. Inability to participate in testing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Electroconvulsive Therapy (ECT); Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT	Device: Electroconvulsive Therapy (n=30); Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.
Active Comparator: Magnetic Seizure Therapy (MST); High-dose magnetic seizure therapy (HD-MST)	Device: Magnetic Seizure Therapy (n=30); High-dose magnetic seizure therapy (HD-MST) over the vertex using Magstim Theta device (Magstim Company Limited, Whitfield, Wales, UK) at 100% maximal output of the device (constant), with pulse frequency 100Hz and train duration 10 seconds twice weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reorientation (TRO)	Cognition primarily assessed by Time to Reorientation (TRO)	approximately 2.5 weeks
Depression Scale	Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)	approximately 2.5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Memory Scale - Revised:	Neuropsychological assessment	approximately 2.5 weeks
Wisconsin Card Sorting Test	Neuropsychological assessment	approximately 2.5 weeks
Brain Single Photon Emission Computed Tomography (SPECT)	Brain SPECT done for patients pre-post MST course to explore biological changes associated with MST and predictors of treatment response.	approximately 2.5 weeks

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Nagy A. Youssef (Consultant on the MST technique)
• Investigators: Principal Investigator: Fatma El-Deeb, MD, PhD, Tanta University, Faculty of Medicine; Principal Investigator: El-Sayed Gad, MD, PhD, Tanta University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2013
• Primary Completion (Actual): October 7, 2015
• Study Completion (Actual): October 7, 2015

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Depression; MDD; Electroconvulsive Therapy; Major Depressive Disorder; ECT; Magnetic seizure therapy; MST; Treatment Resistant Depression (TRD)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: 025

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: No