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

Tanta University60 enrolled

Overview

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).

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Electroconvulsive Therapy (n=30)DEVICE

Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.

Magnetic Seizure Therapy (n=30)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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