Clinical trial NCT03160664: Magnetic Seizure Therapy for Bipolar Mania
Official title: Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder, Manic
Keywords: magnetic seizure therapy
electroconvulsive therapy
bipolar mania
cognition
randomized controlled trial
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: changes in the Young Mania Rating Scale
timeFrame: At baseline, 4-week follow-up
Secondary outcomes:
measure: changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
timeFrame: At baseline and 4-week follow-up
measure: changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
timeFrame: At baseline and 4-week follow-up
measure: changes in the Clinical Global Impression Scale (CGI)
timeFrame: At baseline and 4-week follow-up
measure: changes in the motor threshold (MT)
timeFrame: At baseline and 24 hours after the first treatment
measure: changes in brain gamma-aminobutyric acid （GABA）levels
timeFrame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
measure: changes in the resting state network
timeFrame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
measure: changes in auditory evoked potentials (AEP)
timeFrame: At baseline and 24 hours after the first treatment
measure: changes in the Novel P300
timeFrame: At baseline and 24 hours 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: Jianhua Sheng, PHD
role: PRINCIPAL_INVESTIGATOR
References: