NCT03160664

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

October 31, 2023

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

May 14, 2017

Last Update Submit

October 29, 2023

Conditions

Bipolar Disorder, Manic

Keywords

magnetic seizure therapyelectroconvulsive therapybipolar maniacognitionrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • changes in the Young Mania Rating Scale

    At baseline, 4-week follow-up

Secondary Outcomes (8)

  • changes in the Repeatable Battery for the Assessment of Neuropsychological Status (rRBANS)

    At baseline and 4-week follow-up

  • 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

  • changes in brain gamma-aminobutyric acid （GABA）levels

    At baseline, 24 hours after the first treatment, and at 4-week follow-up

  • +3 more secondary outcomes

Study Arms (2)

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.

Device: Magpro X100 + OptionOther: 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.

Device: ThymatronSystem Ⅳ Electroconvulsive SystemOther: treatment as usual (TAU)

Interventions

Magpro X100 + OptionDEVICE

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.

Also known as: magnetic seizure therapy
magnetic seizure therapy
ThymatronSystem Ⅳ Electroconvulsive SystemDEVICE

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

Also known as: electroconvulsive therapy
electroconvulsive therapy
treatment as usual (TAU)OTHER

Participants will engage in their inpatient treatment program as-usual.

electroconvulsive therapymagnetic seizure therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

  • 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.

    PMID: 38683612DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Jianhua Sheng, PHD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 19, 2017

Study Start

July 1, 2017

Primary Completion

March 3, 2021

Study Completion

April 26, 2021

Last Updated

October 31, 2023

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)