Health TrialsbyHealthPanel

Magnetic Seizure Therapy for Psychotic Disorders

ConditionPsychotic Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Jiao Tong University School of Medicine

About this trial

This trial aims to evaluate the efficacy and safety of Magnetic Seizure Therapy (MST) as an augmentation of antipsychotic medications for psychosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) meets the diagnostic criteria for schizophrenia or other primary psychotic disorders according to DSM-5;

(2) age range between 18 and 55 years;

(3) Positive And Negative Syndrome Scale (PANSS) score≥60;

(4) to provide informed consent.

Disqualifiers

(1) have a concomitant severe medical illness;

(2) are pregnant or intend to get pregnant during the study;

(3) have a history of DSM-5 diagnosis of substance dependence or abuse within the past three months;

(4) history of traumatic brain injury (with a screening scale score of 7 or above);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnetic seizure therapy by Magnetic stimulator

    Device

    The seizure is induced by Magnetic stimulator of MagPro MST(XP)，MagVenture A/S, Farum, Denmark. It is administered in combinations with antipsychotic medications

  • Antipsychotic medications (such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc)

    Drug

    It mainly includes second-generation antipsychotic medications, such as olanzpine, risperidone, aripiprazole, quetiapine, amisulpride, etc, but except clozapine.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Magnetic seizure therapy plus antipsychoticsExperimental treatment 1 intervention
Group B: antipsychotic drugsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Positive and Negative Symptom Scale (PANSS)

measured by Positive and Negative Symptom Scale (PANSS)

Time frame
Baseline, 1 weeks, 2 weeks, 6 weeks

Secondary outcomes

1

Changes in cognition

measured by MCCB cognition tests

Time frame
Baseline, 1 weeks, 2 weeks
2

Changes of ictal EEG feature

measured by electroencephalogram (EEG)

Time frame
during each treatment
3

Changes of cortical inhibition

measured by TMS evoked potentials (TEP)

Time frame
baseline, 2 weeks
4

Changes of brain grey matter

measured by structural MRI images of brain

Time frame
baseline, 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jiao Tong University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
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