Clinical trial NCT03007628: Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Schizophrenia
Official title: Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: magnetic seizure therapy
electroconvulsive therapy
controlled trial
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety among schizophrenia patients. Half of the participants will be randomized to MST group, while the other half will be randomized to 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.

However, MST and ECT may both works via alterations of cortical inhibition and default mode network.

Eligibility criteria: Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia;
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 positive and negative syndrome scale (PANSS)\[20\] score ≥ 60;
4. informed consent in written form.

Exclusion Criteria:

1. 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. other conditions that investigators consider to be inappropriate to participate in this trial.

Primary outcomes:
measure: Changes in the Positive and Negative Syndrome Scale (PANSS)
timeFrame: At baseline and 4-week follow-up
measure: changes in brain structure
timeFrame: At baseline, the 1 day after the first treatment, and at 4-week follow-up
Secondary outcomes:
measure: Changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: At baseline and 4-week follow-up
measure: Changes in Clinical Global Impressions (CGI)
timeFrame: At baseline and 4-week follow-up
measure: Changes in motor threshold (MT)
timeFrame: At baseline and the day after the first treatment
measure: Changes in brain gamma-aminobutyric acid （GABA）levels
timeFrame: At baseline, between the first treatment and the second treatment, and at 4-week follow-up
measure: Changes in resting state network (RSN)
timeFrame: At baseline, the day after the first treatment, and at 4-week follow-up
measure: Changes in auditory evoked potential (AEP)
timeFrame: At baseline and the day after the first treatment
measure: Changes in novel P300 potential
timeFrame: At baseline and the day after the first treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jijun Wang, PHD
role: PRINCIPAL_INVESTIGATOR
References: