Bipolar Disorder, Manic
Conditions
Keywords
magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, randomized controlled trial
Brief summary
This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety for bipolar mania. 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.
Interventions
DEVICEMagpro X100 + Option
In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks
OTHERtreatment as usual (TAU)
Participants will engage in their inpatient treatment program as-usual.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. DSM-5 diagnosis of bipolar I disorder and currently in a manic 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 Young Mania Rating Scale (YMRS) score ≥ 10; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in the Young Mania Rating Scale | At baseline, 4-week follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in the Montgomery Åsberg Depression Rating Scale (MADRS) | At baseline and 4-week follow-up | — |
| changes in the Clinical Global Impression Scale (CGI) | At baseline and 4-week follow-up | — |
| changes in the motor threshold (MT) | At baseline and 24 hours after the first treatment | using single-pulse Transcranial Magnetic Stimulation (sTMS) |
| changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS) | At baseline and 4-week follow-up | — |
| changes in the resting state network | At baseline, 24 hours after the first treatment, and at 4-week follow-up | measured by Magnetic Resonance Imaging (MRI) |
| changes in auditory evoked potentials (AEP) | At baseline and 24 hours after the first treatment | measured by electroencephalogram (EEG) |
| changes in the Novel P300 | At baseline and 24 hours after the first treatment | measured by electroencephalogram (EEG) |
| changes in brain gamma-aminobutyric acid （GABA）levels | At baseline, 24 hours after the first treatment, and at 4-week follow-up | measured by Magnetic Resonance Spectroscopy (MRS) |
Countries
China
Outcome results
None listed