Major Depressive DisorderPhase 2/3NCT04216095
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder
A Phase 2/3 study testing Electroconvulsive Therapy (n=30) and Magnetic Seizure Therapy (n=30) in people with Major Depressive Disorder, run by Tanta University.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Electroconvulsive Therapy (n=30) and Magnetic Seizure Therapy (n=30)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2013to 7 Oct 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Dementia,
- Delirium
- History of significant head trauma
- Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
- Substance dependence
- Active comorbidity with another psychiatric disorder
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- 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
About this study
Official title: Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) 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).
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Electroconvulsive Therapy (n=30), Magnetic Seizure Therapy (n=30)
- Keywords
- MST, ECT, MDD, Depression, Major Depressive Disorder, Magnetic seizure therapy, Electroconvulsive Therapy, Treatment Resistant Depression (TRD)
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroconvulsive Therapy (ECT) | Active comparator | Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT Receives: Device: Electroconvulsive Therapy (n=30) |
| Magnetic Seizure Therapy (MST) | Active comparator | High-dose magnetic seizure therapy (HD-MST) Receives: Device: Magnetic Seizure Therapy (n=30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reorientation (TRO)
Cognition primarily assessed by Time to Reorientation (TRO)
Measured: approximately 2.5 weeks
Depression Scale
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
Measured: approximately 2.5 weeks
Secondary outcomes (3)
Wechsler Memory Scale - Revised:
Neuropsychological assessment
Measured: approximately 2.5 weeks
Wisconsin Card Sorting Test
Neuropsychological assessment
Measured: 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.
Measured: approximately 2.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start7 Jun 2013
- Primary completion7 Oct 2015
- Study completion7 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Nagy A. Youssef (Consultant on the MST technique)
- Responsible party
- Principal investigator, El-Sayed Gad, Tanta University
- Investigators
- Fatma El-Deeb, MD, PhD, Principal investigator, Tanta University, Faculty of MedicineEl-Sayed Gad, MD, PhD, Principal investigator, Tanta University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216095
- Sponsor's protocol ID
- 025
- Status last verified
- Jan 2020
- First submitted
- 23 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04216095
- Acronym / sponsor ID
- 025
- Conditions
- Major Depressive Disorder
- Keywords
- MST, ECT, MDD, Depression, Major Depressive Disorder, Magnetic seizure therapy, Electroconvulsive Therapy, Treatment Resistant Depression (TRD)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Nagy A. Youssef (Consultant on the MST technique)
- Study start
- 7 Jun 2013 (actual)
- Primary completion
- 7 Oct 2015 (actual)
- Study completion
- 7 Oct 2015 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electroconvulsive Therapy (ECT) | Active comparator | Device: Electroconvulsive Therapy (n=30)Right unilateral (RUL, N=15), or Bitemporal (BT, N=15) ECT |
| Magnetic Seizure Therapy (MST) | Active comparator | Device: Magnetic Seizure Therapy (n=30)High-dose magnetic seizure therapy (HD-MST) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Dementia,
- Delirium
- History of significant head trauma
- Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
- Substance dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Electroconvulsive Therapy (ECT) |
| 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. | Device | Magnetic Seizure Therapy (MST) |
Primary outcome
Time to reorientation (TRO)
Time frame: approximately 2.5 weeks
Cognition primarily assessed by Time to Reorientation (TRO)
Depression Scale
Time frame: approximately 2.5 weeks
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
3 secondary outcomes
Wechsler Memory Scale - Revised:
Time frame: approximately 2.5 weeks
Wisconsin Card Sorting Test
Time frame: approximately 2.5 weeks
Brain Single Photon Emission Computed Tomography (SPECT)
Time frame: approximately 2.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma El-Deeb, MD, PhD principal investigator
Tanta University, Faculty of Medicine
El-Sayed Gad, MD, PhD principal investigator
Tanta University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Electroconvulsive Therapy (n=30) and Magnetic Seizure Therapy (n=30) in people with Major Depressive Disorder, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reorientation (TRO) (time frame: approximately 2.5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.