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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
A Pilot Study of the Use of Magnetic Seizure Therapy for Depression
Scientific title
A Pilot Study of the Use of Magnetic Seizure Therapy for Treatment Resistant Depression
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Depression 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Devices - MST

Experimental: Active Treatment -

Treatment: Devices: MST
Magnetic Seizure Therapy

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Timepoint [1] 0 0
2 weeks
Secondary outcome [1] 0 0
Cognitive Assessment
Timepoint [1] 0 0
2 - 6 weeks

Key inclusion criteria
1. Have a DSM-IV diagnosis of a major depressive episode

2. Are referred for or an outpatient course of ECT at the Alfred Hospital

3. Age 18-75

4. Have a Montgomery-Asberg Depression Rating Scale (MADRS) score of > 25 (moderate -
severe depression)

5. Demonstration of capacity to give informed consent: this will be assessed by the study
psychiatrist as well as the patient's primary treating psychiatrist.
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Have an unstable medical condition, or neurological disorder or are currently pregnant
or lactating.

2. Patients not considered sufficiently well to undergo general anaesthesia for any

3. Patients with cardiac pacemakers, cochlear implants or other implanted electronic
devices. Patients with non-electric metallic implants will also be excluded.

4. Significant concurrent axis 1 or 11 psychiatric comorbidity.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Psychiatry Research Centre - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran

Funding & Sponsors
Primary sponsor type
Bayside Health

Ethics approval
Ethics application status

Brief summary
Electro convulsive therapy (ECT) remains the only established therapy for the large
percentage of patients with depression who fail to respond to standard treatments. It is
commonly used but has substantial problems including the occurrence of cognitive side effects
that are often highly distressing for patients. The development of a new treatment with
similar efficacy but which minimises these side effects would have great clinical value. One
highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the
electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to
produce similar clinical effects but without the disabling cognitive side effects related to
ECT. However, substantive trials using the newest MST equipment are required. Due to the
rarity of the equipment available so far, these are only being undertaken in a handful of
places internationally and no research with MST has occurred in Australia. The investigators
are fortunate to have been able to obtain one of the very limited number of MST devices
available internationally and are proposing a pilot study of this technique. Conduct of a
successful pilot study would be strong justification for an application for a large
head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT
but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical
practice throughout Australia and indeed internationally with substantial ongoing benefits to
patients. These would include enhanced use of it as an outpatient therapy as well as the
reduction in side-effects.

The study will be an open label trial of MST in 15 patients with treatment resistant
depression who have been referred for ECT. All patients will undergo a dose titration
procedure to establish seizure threshold, six MST treatment sessions will then be provided at
120% of threshold. If the patients have not achieved a 50% reduction in their depressive
symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients
will receive another 12 sessions. MST will be administered three times a week. Patients will
undergo a series of assessments to determine both the efficacy of MST and the cognitive
outcomes. The primary outcome measure will be the MADRS measure of depression severity. The
investigators will additionally measure patient rated depression severity and cognitive
functioning The overall aim of the current project is to, via an open label pilot trial,
investigate the clinical response to magnetic seizure therapy in patients with treatment
resistant depression who have been referred for electroconvulsive therapy.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications