NCT03016104

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

December 21, 2016

Last Update Submit

May 5, 2022

Conditions

Bipolar Disorder, Manic

Keywords

magnetic seizure therapyelectroconvulsive therapybipolar maniacognitioncontrolled trial

Outcome Measures

Primary Outcomes (1)

  • changes in The Positive and Negative Syndrome Scale (PANSS)

    At baseline, 4-week follow-up, and 8-week follow-up

Secondary Outcomes (7)

  • changes in MATRICS Consensus Cognitive Battery (MCCB)

    At baseline and 4-week follow-up

  • changes in Clinical Global Impressions (CGI)

    At baseline and 4-week follow-up

  • changes in motor threshold (MT)

    At baseline and the day after the first treatment

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

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

  • changes in resting state network

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

  • +2 more secondary outcomes

Study Arms (2)

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.

Device: Magpro X100 + OptionOther: 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.

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 positive and negative syndrome scale (PANSS) score ≥ 60;
  • informed consent in written form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Chunbo Li, PHD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

January 10, 2017

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)