Magnetic Seizure Therapy Versus Electroconvulsive Therapy for Schizophrenia

NCT03007628 | Completed DMC

• 1 other identifier: 14411961400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and its safety among schizophrenia patients. Half of the participants will be randomized to MST group, while the other half will be randomized to receive electroconvulsive therapy (ECT).

Conditions

Schizophrenia

Keywords

magnetic seizure therapy; electroconvulsive therapy; controlled trial

Outcome Measures

Primary Outcomes (2)

• Changes in the Positive and Negative Syndrome Scale (PANSS)

  At baseline and 4-week follow-up

• changes in brain structure

  measured by Magnetic Resonance Imaging (MRI)

  At baseline, the 1 day after the first treatment, and at 4-week follow-up

Secondary Outcomes (7)

• Changes in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  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, between the first treatment and the second treatment, and at 4-week follow-up

• Changes in resting state network (RSN)

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

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; 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.

Device: ThymatronSystem Ⅳ Electroconvulsive System; Other: Treatment as usual (TAU)

Interventions

Magpro X100 DEVICE

In addition to treatment as usual (TAU), participants are 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 System DEVICE

In addition to treatment as usual (TAU), participants are 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 intpatient treatment program as-usual.

electroconvulsive therapy; magnetic seizure therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-5 diagnosis of schizophrenia;
• 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)\[20\] 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jijun Wang, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

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 20, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)