Clinical trial NCT06409325: Effectiveness of MST Versus ECT for Major Depressive Episode
Official title: Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Electroconvulsive therapy (ECT)
magnetic seizure therapy (MST)
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present clinical protocol is designed as a double-blind, parallel, non-inferiority, randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Participants will be randomly allocated to either the ECT or MST group. Each center aims to recruit 30 participants for each group, using block randomization, resulting in a total of 30 participants per group. The trial comprises a 12-session intervention phase of ECT/MST, spanning approximately 4 weeks, followed by a 12-week observation period. For the first three treatment sessions, participants will receive consecutive sessions. Subsequently, there will be a one-day interval between sessions 4 to 6, a two-day interval between sessions 7 to 9, and a three-day interval between sessions 10 to 12, ensuring completion within a month. Following treatment completion, participants will undergo follow-up clinical observations every four weeks for 12 weeks. EEG and ECG recordings will be obtained at baseline, post-session 3, 6, 9, 12 (3 hours after each session), and at the 12-week follow-up. All evaluations will be conducted under standardized conditions throughout the sessions.

Eligibility criteria: 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.

Primary outcomes:
measure: the response rate
timeFrame: 12 weeks
measure: the remission rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: TianHong Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: