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

Major Depressive Disorder Clinical Trial

Official title:

Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216095
• Other study ID #: 025
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 7, 2013
• Est. completion date: October 7, 2015

Study information

• Verified date: January 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 7, 2015
• Est. primary completion date: October 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Nagy A. Youssef (Consultant on the MST technique)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reorientation (TRO)	Cognition primarily assessed by Time to Reorientation (TRO)	approximately 2.5 weeks
Primary	Depression Scale	Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)	approximately 2.5 weeks
Secondary	Wechsler Memory Scale - Revised:	Neuropsychological assessment	approximately 2.5 weeks
Secondary	Wisconsin Card Sorting Test	Neuropsychological assessment	approximately 2.5 weeks
Secondary	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