Back to resultsComparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Electroconvulsive Therapy (n=30)
Magnetic Seizure Therapy (n=30)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring MST, ECT, MDD, Depression, Major Depressive Disorder, Magnetic seizure therapy, Electroconvulsive Therapy, Treatment Resistant Depression (TRD)
Eligibility Criteria
Inclusion Criteria:
- Ability to consent
- Clinically indicated for seizure therapy
- 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)
- 18-65 years of age.
Exclusion Criteria:
- Dementia,
- Delirium
- History of significant head trauma
- Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
- Substance dependence
- Active comorbidity with another psychiatric disorder
- Patients who had previously received ECT or TMS
- Current unstable or serious medical illness (e.g., myocardial infarction)
- Pregnancy
- Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
- Inability to participate in testing
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Electroconvulsive Therapy (ECT)
Magnetic Seizure Therapy (MST)
Arm Description
Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT
High-dose magnetic seizure therapy (HD-MST)
Outcomes
Primary Outcome Measures
Time to reorientation (TRO)
Cognition primarily assessed by Time to Reorientation (TRO)
Depression Scale
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
Secondary Outcome Measures
Wechsler Memory Scale - Revised:
Neuropsychological assessment
Wisconsin Card Sorting Test
Neuropsychological assessment
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.
Full Information
NCT ID
NCT04216095
First Posted
December 23, 2019
Last Updated
January 1, 2020
Sponsor
Tanta University
Collaborators
Nagy A. Youssef (Consultant on the MST technique)
1. Study Identification
Unique Protocol Identification Number
NCT04216095
Brief Title
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
Official Title
Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 7, 2013 (Actual)
Primary Completion Date
October 7, 2015 (Actual)
Study Completion Date
October 7, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Nagy A. Youssef (Consultant on the MST technique)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
MST, ECT, MDD, Depression, Major Depressive Disorder, Magnetic seizure therapy, Electroconvulsive Therapy, Treatment Resistant Depression (TRD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electroconvulsive Therapy (ECT)
Arm Type
Active Comparator
Arm Description
Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT
Arm Title
Magnetic Seizure Therapy (MST)
Arm Type
Active Comparator
Arm Description
High-dose magnetic seizure therapy (HD-MST)
Intervention Type
Device
Intervention Name(s)
Electroconvulsive Therapy (n=30)
Intervention Description
Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.
Intervention Type
Device
Intervention Name(s)
Magnetic Seizure Therapy (n=30)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to reorientation (TRO)
Description
Cognition primarily assessed by Time to Reorientation (TRO)
Time Frame
approximately 2.5 weeks
Title
Depression Scale
Description
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
Time Frame
approximately 2.5 weeks
Secondary Outcome Measure Information:
Title
Wechsler Memory Scale - Revised:
Description
Neuropsychological assessment
Time Frame
approximately 2.5 weeks
Title
Wisconsin Card Sorting Test
Description
Neuropsychological assessment
Time Frame
approximately 2.5 weeks
Title
Brain Single Photon Emission Computed Tomography (SPECT)
Description
Brain SPECT done for patients pre-post MST course to explore biological changes associated with MST and predictors of treatment response.
Time Frame
approximately 2.5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to consent
Clinically indicated for seizure therapy
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)
18-65 years of age.
Exclusion Criteria:
Dementia,
Delirium
History of significant head trauma
Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
Substance dependence
Active comorbidity with another psychiatric disorder
Patients who had previously received ECT or TMS
Current unstable or serious medical illness (e.g., myocardial infarction)
Pregnancy
Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
Inability to participate in testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma El-Deeb, MD, PhD
Organizational Affiliation
Tanta University, Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
El-Sayed Gad, MD, PhD
Organizational Affiliation
Tanta University, Faculty of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
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