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Effectiveness of Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Major Depressive Episode

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
TianHong Zhang, Doctor
zhang_tianhong@126.com
13127577024
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 210
Treatments
Experimental: the MST group
MST was conducted at 100 Hz and 100% output using a pulse width of 350 μs and a peak intensity of the magnetic field at 3.0 Tesla. The duration of magnetic stimulation was titrated using a 10-second train duration, starting from 2 seconds and increasing by 4 seconds in subsequent sessions, up to a maximum of 10 seconds (i.e., 200-1,000 pulses per session). In cases of poor seizure quality (\<15 s), the stimulation duration increment was set to 6 seconds in the next session. If no seizures were elicited, an additional 10-second stimulation was administered immediately. Subsequent MST treatments were maintained at a 10-second duration for a total of 1000 pulses.
Active_comparator: the ECT group
For ECT, the pulse width of the electrical stimulus was set to 0.5 ms. The initial energy dosage was determined based on the patient's age, with subsequent sessions increasing by 5% increments. In cases of inadequate seizure duration (\<25 s), the maximum dosage was administered in the following session. If no seizures were induced, the maximum dosage was administered immediately.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov

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