Bipolar Disorder, ManicNCT03160664

Magnetic Seizure 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: 48 participants
Where: 1 siteChina
Study dates: 1 Jul 2017to 26 Apr 2021
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 Young Mania Rating Scale (YMRS) score ≥ 10;
informed consent in written form.

Who cannot join

primary 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;
Unremovable metal implants.
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

Other trials in China

About this study

Official title: Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients

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, randomized 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
treatment as usual (TAU)Other
Participants will engage in their inpatient treatment program as-usual.

Study groups in NCT03160664
Study group	Role	What they receive
magnetic seizure therapy	Experimental	8-10 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	8-10 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 Young Mania Rating Scale
Measured: At baseline, 4-week follow-up

Secondary outcomes (8)

changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Measured: At baseline and 4-week follow-up
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Measured: At baseline and 4-week follow-up
changes in the Clinical Global Impression Scale (CGI)
Measured: At baseline and 4-week follow-up
changes in the motor threshold (MT)
using single-pulse Transcranial Magnetic Stimulation (sTMS)
Measured: At baseline and 24 hours after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
measured by Magnetic Resonance Spectroscopy (MRS)
Measured: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in the resting state network
measured by Magnetic Resonance Imaging (MRI)
Measured: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in auditory evoked potentials (AEP)
measured by electroencephalogram (EEG)
Measured: At baseline and 24 hours after the first treatment
changes in the Novel P300
measured by electroencephalogram (EEG)
Measured: At baseline and 24 hours 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.

1 Jul 201726 Apr 2021

First posted19 May 2017
Study start1 Jul 2017
Primary completion3 Mar 2021
Study completion26 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar Disorder, ManicStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03160664
Sponsor's protocol ID: 17411969900
Status last verified: Sep 2021
First submitted: 14 May 2017
Last updated: 31 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen S, Sheng J, Yang F, Qiao Y, Wang W, Wen H, Yang Q, Chen X, Tang Y. Magnetic Seizure Therapy vs Modified Electroconvulsive Therapy in Patients With Bipolar Mania: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247919. doi: 10.1001/jamanetworkopen.2024.7919.
PubMed 38683612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
RecruitingPhase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Bipolar I Disorder, Mania
RecruitingObservational study
Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder
Bipolar Disorder, Depressive Disorder

All Bipolar Disorder, Manic trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research on Optimization Program of Magnetic Seizure Therapy for Bipolar Mania Patients
ClinicalTrials.gov ID: NCT03160664
Acronym / sponsor ID: 17411969900
Conditions: Bipolar Disorder, Manic
Keywords: magnetic seizure therapy, electroconvulsive therapy, bipolar mania, cognition, randomized controlled trial
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Shanghai Mental Health CenterUniversity, hospital or other
Study start: 1 Jul 2017 (actual)
Primary completion: 3 Mar 2021 (actual)
Study completion: 26 Apr 2021 (actual)
First posted: 19 May 2017 (actual)
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.

Detailed description

Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
magnetic seizure therapy	Experimental	Device: Magpro X100 + Option, Other: treatment as usual (TAU)8-10 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)8-10 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 Young Mania Rating Scale (YMRS) score ≥ 10;
informed consent in written form.

Key exclusion criteria (7 listed)

primary 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 Young Mania Rating Scale
Time frame: At baseline, 4-week follow-up

8 secondary outcomes

changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)
Time frame: At baseline and 4-week follow-up
changes in the Montgomery Åsberg Depression Rating Scale (MADRS)
Time frame: At baseline and 4-week follow-up
changes in the Clinical Global Impression Scale (CGI)
Time frame: At baseline and 4-week follow-up
changes in the motor threshold (MT)
Time frame: At baseline and 24 hours after the first treatment
changes in brain gamma-aminobutyric acid （GABA）levels
Time frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in the resting state network
Time frame: At baseline, 24 hours after the first treatment, and at 4-week follow-up
changes in auditory evoked potentials (AEP)
Time frame: At baseline and 24 hours after the first treatment
changes in the Novel P300
Time frame: At baseline and 24 hours after the first treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
Derived from this study: PubMed 38683612Chen S, Sheng J, Yang F, Qiao Y, Wang W, Wen H, Yang Q, Chen X, Tang Y. Magnetic Seizure Therapy vs Modified Electroconvulsive Therapy in Patients With Bipolar Mania: A Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247919. doi: 10.1001/jamanetworkopen.2024.7919.
Individual participant dataSharing planned: No

Related trials for Bipolar Disorder, Manic

RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
RecruitingPhase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Bipolar I Disorder, Mania
RecruitingObservational study
Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder
Bipolar Disorder, Depressive Disorder

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.

Jianhua Sheng, 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?

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 7 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: finished, as of the sponsor's last update on 31 Oct 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Young Mania Rating Scale (time frame: At baseline, 4-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03160664, which also lists 1 linked publication.

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 31 Oct 2023.