Clinical trial NCT04216095: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: MST
ECT
MDD
Depression
Major Depressive Disorder
Magnetic seizure therapy
Electroconvulsive Therapy
Treatment Resistant Depression (TRD)
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Nagy A. Youssef (Consultant on the MST technique)
First posted: 2020-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Time to reorientation (TRO)
timeFrame: approximately 2.5 weeks
measure: Depression Scale
timeFrame: approximately 2.5 weeks
Secondary outcomes:
measure: Wechsler Memory Scale - Revised:
timeFrame: approximately 2.5 weeks
measure: Wisconsin Card Sorting Test
timeFrame: approximately 2.5 weeks
measure: Brain Single Photon Emission Computed Tomography (SPECT)
timeFrame: approximately 2.5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Tanta University, Faculty of Medicine
name: Fatma El-Deeb, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University, Faculty of Medicine
name: El-Sayed Gad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: