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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Magnetic Seizure Therapy (n=30); Device: Electroconvulsive Therapy (n=30)

• Registration Number: NCT04216095
• Lead Sponsor: Tanta University

Brief Summary

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).

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 Timeline

• Study Start: 2013-06-07
• Primary Completion: 2015-10-07
• Study Completion: 2015-10-07
• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Seizure Therapy (MST)	Magnetic Seizure Therapy (n=30)	High-dose magnetic seizure therapy (HD-MST)
Electroconvulsive Therapy (ECT)	Electroconvulsive Therapy (n=30)	Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT

Primary Outcome Measures

Name	Time	Method
Time to reorientation (TRO)	approximately 2.5 weeks	Cognition primarily assessed by Time to Reorientation (TRO)
Depression Scale	approximately 2.5 weeks	Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)

Secondary Outcome Measures

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