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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216095
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : January 3, 2020
Sponsor:
Collaborator:
Nagy A. Youssef (Consultant on the MST technique)
Information provided by (Responsible Party):
El-Sayed Gad, 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).

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : June 7, 2013
Actual Primary Completion Date : October 7, 2015
Actual Study Completion Date : October 7, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

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.




Primary Outcome Measures :
  1. Time to reorientation (TRO) [ Time Frame: approximately 2.5 weeks ]
    Cognition primarily assessed by Time to Reorientation (TRO)

  2. Depression Scale [ Time Frame: approximately 2.5 weeks ]
    Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)


Secondary Outcome Measures :
  1. Wechsler Memory Scale - Revised: [ Time Frame: approximately 2.5 weeks ]
    Neuropsychological assessment

  2. Wisconsin Card Sorting Test [ Time Frame: approximately 2.5 weeks ]
    Neuropsychological assessment

  3. Brain Single Photon Emission Computed Tomography (SPECT) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216095


Sponsors and Collaborators
Tanta University
Nagy A. Youssef (Consultant on the MST technique)
Investigators
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Principal Investigator: Fatma El-Deeb, MD, PhD Tanta University, Faculty of Medicine
Principal Investigator: El-Sayed Gad, MD, PhD Tanta University, Faculty of Medicine
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Responsible Party: El-Sayed Gad, Professor, Tanta University
ClinicalTrials.gov Identifier: NCT04216095    
Other Study ID Numbers: 025
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Sayed Gad, Tanta University:
MST
ECT
MDD
Depression
Major Depressive Disorder
Magnetic seizure therapy
Electroconvulsive Therapy
Treatment Resistant Depression (TRD)
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms