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

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04216095
• Collaborator: Nagy A. Youssef (Consultant on the MST technique) (Other)
• Enrollment: 60
• Arms: 2
• Actual Duration (Months): 28

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Device: Electroconvulsive Therapy (n=30); Device: Magnetic Seizure Therapy (n=30)	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: MST (Magstim Theta device, Magstim Company Limited, Whitfield, Wales, UK) versus ECT (Thymatron IV device, Somatics LLC, USA) assigned per the clinical decision making of the ECT psychiatrist as deemed best for the patient.MST (Magstim Theta device, Magstim Company Limited, Whitfield, Wales, UK) versus ECT (Thymatron IV device, Somatics LLC, USA) assigned per the clinical decision making of the ECT psychiatrist as deemed best for the patient.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
• Actual Study Start Date: Jun 7, 2013
• Actual Primary Completion Date: Oct 7, 2015
• Actual Study Completion Date: Oct 7, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Time to reorientation (TRO) [approximately 2.5 weeks]

   Cognition primarily assessed by Time to Reorientation (TRO)

2. Depression Scale [approximately 2.5 weeks]

   Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)

Secondary Outcome Measures

1. Wechsler Memory Scale - Revised: [approximately 2.5 weeks]

   Neuropsychological assessment

2. Wisconsin Card Sorting Test [approximately 2.5 weeks]

   Neuropsychological assessment

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tanta University
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: El-Sayed Gad, Professor, Tanta University
• ClinicalTrials.gov Identifier: NCT04216095
• Other Study ID Numbers: 025
• First Posted: Jan 2, 2020
• Last Update Posted: Jan 3, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by El-Sayed Gad, Professor, Tanta University: MST; ECT; MDD; Depression; Major Depressive Disorder; Magnetic seizure therapy; Electroconvulsive Therapy; Treatment Resistant Depression (TRD)
• Additional relevant MeSH terms: Disease; Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

No Results Posted as of Jan 3, 2020