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Completed

NCT Number: NCT04216095

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 18-65 years of age.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to reorientation (TRO)

    Time frame: approximately 2.5 weeks

    Cognition primarily assessed by Time to Reorientation (TRO)

  2. Depression Scale

    Time frame: approximately 2.5 weeks

    Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)

Secondary outcomes

  1. Wechsler Memory Scale - Revised:

    Time frame: approximately 2.5 weeks

    Neuropsychological assessment

  2. Wisconsin Card Sorting Test

    Time frame: approximately 2.5 weeks

    Neuropsychological assessment

  3. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Nagy A. Youssef (Consultant on the MST technique)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 2, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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