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

NCT04216095 | Completed Phase 2 DMC

• 1 other identifier: 025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Major Depressive Disorder

Keywords

MST; ECT; MDD; Depression; Major Depressive Disorder; Magnetic seizure therapy; Electroconvulsive Therapy; Treatment Resistant Depression (TRD)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Wechsler Memory Scale - Revised:

  approximately 2.5 weeks

• Wisconsin Card Sorting Test

  approximately 2.5 weeks

• Brain Single Photon Emission Computed Tomography (SPECT)

  approximately 2.5 weeks

Study Arms (2)

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT

Device: Electroconvulsive Therapy (n=30)

Magnetic Seizure Therapy (MST)

ACTIVE COMPARATOR

High-dose magnetic seizure therapy (HD-MST)

Device: Magnetic Seizure Therapy (n=30)

Interventions

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.

Electroconvulsive Therapy (ECT)

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.

Magnetic Seizure Therapy (MST)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to consent
• Clinically indicated for seizure therapy
• 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)
• years of age.

You may not qualify if:

• Dementia,
• Delirium
• History of significant head trauma
• Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
• Substance dependence
• Active comorbidity with another psychiatric disorder
• Patients who had previously received ECT or TMS
• Current unstable or serious medical illness (e.g., myocardial infarction)
• Pregnancy
• Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
• Inability to participate in testing

Sponsors & Collaborators

• Tanta University: lead
• Nagy A. Youssef (Consultant on the MST technique): collaborator

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Fatma El-Deeb, MD, PhD

  Tanta University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• El-Sayed Gad, MD, PhD

  Tanta University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: January 2, 2020
• Study Start: June 7, 2013
• Primary Completion: October 7, 2015
• Study Completion: October 7, 2015
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share