Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT04216095|
Recruitment Status : Completed
First Posted : January 2, 2020
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Electroconvulsive Therapy (n=30) Device: Magnetic Seizure Therapy (n=30)||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|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)|
|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|
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.
- Time to reorientation (TRO) [ Time Frame: approximately 2.5 weeks ]Cognition primarily assessed by Time to Reorientation (TRO)
- Depression Scale [ Time Frame: approximately 2.5 weeks ]Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
- Wechsler Memory Scale - Revised: [ Time Frame: approximately 2.5 weeks ]Neuropsychological assessment
- Wisconsin Card Sorting Test [ Time Frame: approximately 2.5 weeks ]Neuropsychological assessment
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216095
|Principal Investigator:||Fatma El-Deeb, MD, PhD||Tanta University, Faculty of Medicine|
|Principal Investigator:||El-Sayed Gad, MD, PhD||Tanta University, Faculty of Medicine|