ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000054910

Ethics application status

Approved

Date submitted

22/11/2010

Date registered

17/01/2011

Date last updated

26/11/2018

Date data sharing statement initially provided

26/11/2018

Date results provided

26/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating Magnetic Seizure Therapy in Major Depressive Disorder.

Scientific title

A randomised controlled trial of Magnetic Seizure Therapy for the treatment of Major Depressive Disorder

Secondary ID [1]

Project 363/10

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Treatment Resistant Major Depression

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Magnetic Seizure Therapy (MST).

MST uses magnetic stimulation to induce a seizure for therapeutic purposes. Magnetic stimulation is a non invasive technique for stimulating neural tissue. A rapid change in magnetic field induces a current in the neural tissue. If the current is of sufficient amplitude and duration it will excite nerve tissues.

All patients will undergo a dose titration procedure to establish their convulsive stimulation threshold using 10 second trains at 100Hz. Stimulation will then be provided at 120% of seizure threshold. Patients will undergo a maximum of 15 treatment sessions over approximately 5 weeks.

Stimulation is applied using the Magstim Magnetic Seziure Therapy device. Treatment duration is between 20-30 mins.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Electroconvulsive Therapy (ECT).

ECT uses electrical stimulation to induce a therapeutic seizure.

ECT treatment will be based on seizure threshold which will be determined at the first ECT session. In the majority of subjects we will use right unilateral ECT at three times seizure threshold. Only those patients who have a history of no response to an effective course of unilateral ECT will commence with bilateral ECT at 1.5 times seizure threshold

Patients will undergo a maximum of 15 treatment sessions over approximately 5 weeks.

Stimulation is applied using the Thymatron device. Treatment duration is between 20-30 mins.

Control group

Active

Outcomes

Primary outcome [1]

Antidepressant effect.

Montgomery Asberg Depression Rating Scale (MADRS)

Response is defined as a reduction of at least 50% from baseline.

Timepoint [1]

MADRS will be assessed at baseline, weekly during treatment, at treatment end, and for responders at 2, 4 and 6 months following treament end.

Secondary outcome [1]

Cognitive side effects.

A comprehensive cogntive battery will be administered. The battery will include the Autobiographical Memory Interview, Rey Verbal Auditory Learning Test , Verbal Paired Associates (WMS-R), Logical Memory (WMS-III), and the Brief Visual Spatial Memory Test. We will also include a number of assessments of information processing, i.e. Digit Span, Digit Symbol Coding, and Trail Making Test. Finally, we will look at general intellectual functioning (Wechsler Test of Adult Reading), as well as aspects of executive functioning and language (Rey Complex Figure Test, Stroop, Verbal Fluency and Boston Naming Test).

Post treatment Orientation will also be assessed. Patients will be repeatedly asked to provide their name, date of birth, age, place and day of week. Orientation will be considered to be present when the patient provides correct answers to 4 of these questions.

Timepoint [1]

The Cognitive battery will be administered at baseline, endpoint and at 6 months follow up.

Post MST / ECT orientation will be assessed immediately following the first, fourth and ninth treatments.

Eligibility

Key inclusion criteria

Age 18-75 and a DSM-IV diagnosis of a major depressive episode (uni or bipolar depression) (diagnosis made using the standard structured clinical interview for the DSM-IV (SCID I) instrument).

Patients with psychotic symptoms as part of their mood episode will not be excluded if able to give informed consent.

Are referred for or are otherwise suitable for a course of ECT as determined by their treating psychiatrist

Hamilton Depression Rating Scale (17 item version) score of > 18 (moderate – severe depression): note – some authors have defined moderate depression on the 17 item HAMD as >14. We have selected a higher cut off to ensure all patients clearly have depression of substantial clinical severity. It is likely that most patients will have scores in the severe or extremely severe ranges.

Score greater than 23 on the Mini Mental State Examination

Have treatment resistant depression at Stage II of the Thase and Rush classification. This requires failure to respond to adequate courses of several courses of antidepressants.

Demonstrated capacity to give informed consent

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients who are too unwell to undergo general anesthetic.

Patients with metallic implants in the head, cardiac pacemakers, cochlear implants or other implanted electronic devices

Treatment with ECT in the last three months

Presence of another DSM-IV Axis I psychiatric disorder (on SCID I) other than bipolar disorder

Presence of substance abuse or dependence during the last six months (on SCID I)

Current pregnancy

Past history of stroke, neurodegenerative disorder or other major neurological illness

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealment occurs through central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Individuals are randomized (single non stratified sequence) via a computer-generated list

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2011

Actual

2/03/2011

Date of last participant enrolment

Anticipated

Actual

8/09/2015

Date of last data collection

Anticipated

Actual

1/06/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Paul Fitzgerald

Address

Monash Alfred Psychiatry Research Centre (MAPrc): Level 4, St Kilda Rd, Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Alfred Hospital

Address [1]

55 Commercial Road
PO Box 315 Prahran
Victoria 3181 Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Human Research Ethics Committee

Ethics committee address [1]

Research & Ethics Unit
Linay Pavilion

55 Commercial Road
PO Box 315 Prahran
Victoria 3181 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/11/2010

Approval date [1]

21/12/2010

Ethics approval number [1]

1/10/0363

Summary

Brief summary

Electro convulsive therapy (ECT) remains the only established treatment for the large percentage of patients with depression who fail to respond to standard therapies. It is commonly used (with 10 to 15% of inpatients with depression receiving ECT) but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. ECT is associated with both short term and long term cognitive side effects. The short term effects include anterograde and retrograde memory loss and post treatment disorientation which can be distressing, dangerous and significantly slow treatment progress. In the longer term, ECT can affect autobiographical memory which can be very distressing to patients. The development of a new treatment with similar efficacy but which minimises these side effects would have great clinical value. 

A 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 studies are only being undertaken in a handful of places internationally and no research with MST has occurred.

Building on a pilot study conducted by the applicants, we propose to undertake a substantive head-to-head trial of MST versus ECT. There will be a total of 60 patients in the study undertaking a treatment course of between 9 and 15 treatments.  Baseline and endpoint assessments will be undertaking to investigate efficacy, these will include clinical assessments, cognitive assessments and neurophysiological assessment

If MST proves to be as efficacious as ECT, but with fewer side effects, we anticipate that it could be rapidly adopted in clinical practice. All of the facilities are available for the provision of MST in every substantive mental health service in the country (in current ECT suites / facilities); all that would be required would be the replacement of the ECT machine with MST equipment for seizure induction. Fewer cognitive side effects will enhance patient outcomes and improve treatment acceptability and hence access. In addition, a reduced duration of post treatment disorientation will shorten the period of post treatment observation required enhancing capacity for convulsive therapy to be provided on an outpatient basis, lessening demand on inpatient psychiatric services.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Paul Fitzgerald

Address

MAPrc Level 4, St Kilda Rd, Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9076 6552

Fax

p.fitzgerald@alfred.org.au

Contact person for public queries

Name

Paul Fitzgerald

Address

MAPrc Level 4, St Kilda Rd, Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9076 6552

Fax

p.fitzgerald@alfred.org.au

Contact person for scientific queries

Name

Paul Fitzgerald

Address

MAPrc Level 4, St Kilda Rd, Melbourne VIC 3004

Country

Australia

Phone

+ 61 3 9076 6552

Fax

p.fitzgerald@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

will require ethical approval

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot study of the comparative efficacy of 100 Hz magnetic seizure therapy and electroconvulsive therapy in persistent depression.	2018	https://dx.doi.org/10.1002/da.22715

N.B. These documents automatically identified may not have been verified by the study sponsor.

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