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| Name | Class |
|---|---|
| Nagy A. Youssef (Consultant on the MST technique) | UNKNOWN |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroconvulsive Therapy (ECT) | Active Comparator | Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT |
|
| Magnetic Seizure Therapy (MST) | Active Comparator | High-dose magnetic seizure therapy (HD-MST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive Therapy (n=30) | Device | Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reorientation (TRO) | Cognition primarily assessed by Time to Reorientation (TRO) | approximately 2.5 weeks |
| Depression Scale | Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21) | approximately 2.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Memory Scale - Revised: | Neuropsychological assessment | approximately 2.5 weeks |
| Wisconsin Card Sorting Test | Neuropsychological assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatma El-Deeb, MD, PhD | Tanta University, Faculty of Medicine | Principal Investigator |
| El-Sayed Gad, MD, PhD | Tanta University, Faculty of Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| D061218 | Depressive Disorder, Treatment-Resistant |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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.
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| Magnetic Seizure Therapy (n=30) | Device | 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. |
|
| approximately 2.5 weeks |
| 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. | approximately 2.5 weeks |
| D001519 |
| Behavior |