Clinical trial NCT03016104: Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
Official title: Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bipolar Disorder, Manic
Keywords: magnetic seizure therapy
electroconvulsive therapy
bipolar mania
cognition
controlled trial
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 0
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 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 positive and negative syndrome scale (PANSS) 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, 4-week follow-up, and 8-week follow-up
Secondary outcomes:
measure: changes in MATRICS Consensus Cognitive Battery (MCCB)
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, the day after the first treatment, and at 4-week follow-up
measure: changes in resting state network
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
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: Chunbo Li, PHD
role: PRINCIPAL_INVESTIGATOR
References: