Clinical trial NCT03841019: Predict MDE Outcomes After MST
Official title: Research on the Prediction of Clinical Response to Magnetic Seizure Therapy for Patients With Major Depression Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Episode
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for major depressive episode. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).

Detailed description: Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).

Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Eligibility criteria: Inclusion Criteria:

1. DSM-5 diagnosis of major depressive episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the HAMD-17 ≥ 24;
4. informed consent in written form.

Exclusion Criteria:

1. primary diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. Unremovable metal implants.
7. other conditions that investigators consider to be inappropriate to participate in this trial.

Primary outcomes:
measure: changes in the 17-item Hamilton Depression Rating Scale (HAMD-17)
timeFrame: At baseline and 4-week follow-up
Secondary outcomes:
measure: changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state
timeFrame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the auditory mismatch negativity task
timeFrame: At baseline and 4-week follow-up
measure: changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.
timeFrame: At baseline and 4-week follow-up
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jianhua Sheng, PHD
role: PRINCIPAL_INVESTIGATOR
References: