Effectiveness of MST Versus ECT for Major Depressive Episode
Recruiting · NCT06409325 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ECTMST
What this trial is about
Despite advancements in Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) for Major Depressive Disorder (MDD), there remains a need for further research to replicate clinical outcomes and understand the therapeutic targets of these treatments. This study aims to address these gaps through a double-blinded, randomized, non-inferiority investigation comparing the efficacy, tolerability, cognitive adverse effects, and neurophysiological biomarkers of MST and bilateral ECT in patients with MDD.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participants must meet the diagnostic criteria for MDD as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Participants must have a baseline score of 18 or higher on the 24-item Hamilton Depression Rating Scale (HDRS-24).
- During the trial's treatment period, participants must be using a single antidepressant medication at a stable dose.
- Participants must be between the ages of 18 and 65 years.
- Informed consent from both parents and legal guardians is required.
Exclusion criteria
- Individuals with current or history of organic brain disorders or neurological disorders will be excluded from the study.
- Participants with a Wechsler Abbreviated Scale of Intelligence (WASI) score of less than 70 will be excluded.
- Individuals currently taking antiepileptic drugs, benzodiazepines, or other medications that may affect seizure activity will be excluded from the study.
- Those with exposure to ECT, modified ECT, MST, transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neurostimulation treatments in last 6 months will be excluded.
- Individuals with cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain will be excluded from participation.
- Pregnant or lactating individuals will be excluded from the study.
- Individuals currently participating in another concurrent clinical trial will not be eligible for inclusion.
- Participants who refuse to provide informed consent to participate in the trial will be excluded.
- Other circumstances deemed unsuitable for participation by researchers will result in exclusion.
Where it is running
1 location listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China