50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

NCT03003156 | Completed DMC

• 1 other identifier: SHDC12014111a
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This trial attempts to investigate whether the dosage (frequency) has an effect on the treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST, while the other half will be recruited to 50 Hz MST.

Conditions

Schizophrenia

Keywords

magnetic seizure therapy; schizophrenia; controlled trial; cognition

Outcome Measures

Primary Outcomes (1)

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

  At baseline, 4-week follow-up

Secondary Outcomes (3)

• changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  At baseline and 4-week follow-up

• seizure duration

  at each treatment session, up to 4 weeks

• Adverse events

  up to 4 weeks

Study Arms (2)

25 Hz magnetic seizure therapy

EXPERIMENTAL

10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.

Procedure: 25 Hz magnetic seizure therapy

50 Hz magnetic seizure therapy

EXPERIMENTAL

10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.

Procedure: 50 Hz magnetic seizure therapy

Interventions

25 Hz magnetic seizure therapy PROCEDURE

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

25 Hz magnetic seizure therapy

50 Hz magnetic seizure therapy PROCEDURE

In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.

50 Hz 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

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chunbo Li, 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 16, 2016
• First Posted: December 26, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)