NCT06409325Recruiting
Effectiveness of MST Versus ECT for Major Depressive Episode
Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode
Source: ClinicalTrials.gov · Last updated 22 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 7 May 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Depression
- NCT number
- NCT06409325
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 1 Aug 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals currently taking antiepileptic drugs, benzodiazepines, or other medications that may affect seizure activity will be excluded from the study.
- Individuals currently participating in another concurrent clinical trial will not be eligible for inclusion.
Other illness
- Individuals with current or history of organic brain disorders or neurological disorders will be excluded from the study.
- Individuals with cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain will be excluded from participation.
Other
- Participants with a Wechsler Abbreviated Scale of Intelligence (WASI) score of less than 70 will be excluded.
- 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.
- Pregnant or lactating individuals will be excluded from the study.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.