Bipolar Disorder, ManicNCT03016104
Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
A study testing Magpro X100 + Option, ThymatronSystem Ⅳ Electroconvulsive System and treatment as usual (TAU) in people with Bipolar Disorder, Manic, run by Shanghai Mental Health Center at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Manic
- What is being tested?
- Magpro X100 + Option, ThymatronSystem Ⅳ Electroconvulsive System and treatment as usual (TAU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
- convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
- the positive and negative syndrome scale (PANSS) score ≥ 60;
- informed consent in written form.
Who cannot join
- diagnosis of other mental disorders;
- severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
- present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
- failure to respond to an adequate trial of ECT lifetime;
- are pregnant or intend to get pregnant during the study;
- other conditions that investigators consider to be inappropriate to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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).
Read the 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.
- Conditions
- Bipolar Disorder, Manic
- Being tested
- Magpro X100 + Option, ThymatronSystem Ⅳ Electroconvulsive System, treatment as usual (TAU)
- Keywords
- magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, controlled trial
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magpro X100 + OptionDevice
Also called magnetic seizure therapy
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.
ThymatronSystem Ⅳ Electroconvulsive SystemDevice
Also called electroconvulsive therapy
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
Participants will engage in their inpatient treatment program as-usual.
| Study group | Role | What they receive |
|---|---|---|
| magnetic seizure therapy | Experimental | 10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks. Receives: Device: Magpro X100 + Option; Other: treatment as usual (TAU) |
| electroconvulsive therapy | Active comparator | 10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks. Receives: Device: ThymatronSystem Ⅳ Electroconvulsive System; Other: treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in The Positive and Negative Syndrome Scale (PANSS)
Measured: At baseline, 4-week follow-up, and 8-week follow-up
Secondary outcomes (7)
changes in MATRICS Consensus Cognitive Battery (MCCB)
Measured: At baseline and 4-week follow-up
changes in Clinical Global Impressions (CGI)
Measured: At baseline and 4-week follow-up
changes in motor threshold (MT)
using single-pulse Transcranial Magnetic Stimulation (sTMS)
Measured: At baseline and the day after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
measured by Magnetic Resonance Spectroscopy (MRS)
Measured: At baseline, the day after the first treatment, and at 4-week follow-up
changes in resting state network
measured by Magnetic Resonance Imaging (MRI)
Measured: At baseline, the day after the first treatment, and at 4-week follow-up
changes in auditory evoked potential (AEP)
measured by electroencephalogram (EEG)
Measured: At baseline and the day after the first treatment
changes in Novel P300
measured by electroencephalogram (EEG)
Measured: At baseline and the day after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The problems of MST device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, ManicStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunbo Li, PHD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016104
- Sponsor's protocol ID
- SHDC12014111b
- Status last verified
- May 2022
- First submitted
- 21 Dec 2016
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania
- ClinicalTrials.gov ID
- NCT03016104
- Acronym / sponsor ID
- SHDC12014111b
- Conditions
- Bipolar Disorder, Manic
- Keywords
- magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, controlled trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The problems of MST device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnetic seizure therapy | Experimental | Device: Magpro X100 + Option, Other: treatment as usual (TAU)10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks. |
| electroconvulsive therapy | Active comparator | Device: ThymatronSystem Ⅳ Electroconvulsive System, Other: treatment as usual (TAU)10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;
- convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
- the positive and negative syndrome scale (PANSS) score ≥ 60;
- informed consent in written form.
Key exclusion criteria (6 listed)
- diagnosis of other mental disorders;
- severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
- present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
- failure to respond to an adequate trial of ECT lifetime;
- are pregnant or intend to get pregnant during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magpro X100 + OptionAlso: magnetic seizure therapyIn 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. | Device | magnetic seizure therapy |
| ThymatronSystem Ⅳ Electroconvulsive SystemAlso: electroconvulsive therapyIn 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 | Device | electroconvulsive therapy |
| treatment as usual (TAU)Participants will engage in their inpatient treatment program as-usual. | Other | electroconvulsive therapy, magnetic seizure therapy |
Primary outcome
changes in The Positive and Negative Syndrome Scale (PANSS)
Time frame: At baseline, 4-week follow-up, and 8-week follow-up
7 secondary outcomes
changes in MATRICS Consensus Cognitive Battery (MCCB)
Time frame: At baseline and 4-week follow-up
changes in Clinical Global Impressions (CGI)
Time frame: At baseline and 4-week follow-up
changes in motor threshold (MT)
Time frame: At baseline and the day after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
Time frame: At baseline, the day after the first treatment, and at 4-week follow-up
changes in resting state network
Time frame: At baseline, the day after the first treatment, and at 4-week follow-up
changes in auditory evoked potential (AEP)
Time frame: At baseline and the day after the first treatment
changes in Novel P300
Time frame: At baseline and the day after the first treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunbo Li, PHD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magpro X100 + Option, ThymatronSystem Ⅳ Electroconvulsive System and treatment as usual (TAU) in people with Bipolar Disorder, Manic, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in The Positive and Negative Syndrome Scale (PANSS) (time frame: At baseline, 4-week follow-up, and 8-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.