Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000406404
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
30/03/2016
Date last updated
11/11/2020
Date data sharing statement initially provided
11/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Magnetic Seizure Therapy in Major Depressive Disorder
Scientific title
A Randomised Clinical Trial comparing two alternate forms of Magnetic Seizure Therapy for major depressive disorder
Secondary ID [1] 287930 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment Resistant Major Depression 296807 0
Condition category
Condition code
Mental Health 297036 297036 0 0
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 initially undergo a dose titration procedure to establish their convulsive stimulation threshold. Single stimulation trains will be applied at 25 Hz to the prefrontal cortex.

Patients will undergo a maximum of 15 treatment sessions over approximately 5 weeks. Treatment will be administered a psychiatric medical registrar with an anesthetist present. Number of treatment sessions will be determined by Professor Paul Fitzgerald (CI) on the basis of consultation with participant regarding their wishes and mental state.

Stimulation is applied using the Magstim Magnetic Seziure Therapy device. Treatment duration is between 20-30 mins. Each treatment will be recorded (date, time of treatment and duration) by a research nurse.
Intervention code [1] 293279 0
Treatment: Devices
Comparator / control treatment
Magnetic Seizure Therapy (MST).

All patients will initially undergo a dose titration procedure to establish their convulsive stimulation threshold. Single stimulation trains will be at 100 Hz to the vertex.

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.
Control group
Active

Outcomes
Primary outcome [1] 296635 0
Antidepressant effect.

Montgomery Asberg Depression Rating Scale (MADRS)

Response is defined as a reduction of at least 50% from baseline.
Timepoint [1] 296635 0
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] 318958 0
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] 318958 0
The Cognitive battery will be administered at baseline and endpoint. Endpoint will be post 12 or 15 treatments, the total number of treatments is dependent on consultation by psychiatrist and participant)
Secondary outcome [2] 318959 0
Electrovestibulography (EVestG)

EVestG measures neural responses via probes placed in the ear canal. It involves having an electrode placed in the ear which measures brain activity while the participant sits in a chair that is slowly being tilted forward and back as well as side to side.

This assessment will allow us to investigate whether MST results in changes in brain activity.
Timepoint [2] 318959 0
EVestG will be conducted at baseline and following treatment 3.

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.

?Montgomery Asberg depression rating scale (MADRS) score of > 20(moderate – severe depression).

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?
No
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 two months

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

Presence of substance abuse or dependence during the last six months

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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/04/2016
Actual
29/03/2016
Date of last participant enrolment
Anticipated
Actual
1/05/2017
Date of last data collection
Anticipated
1/11/2019
Actual
1/05/2017
Sample size
Target
80
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292408 0
Government body
Name [1] 292408 0
National Health and Medical Research Council
Country [1] 292408 0
Australia
Primary sponsor type
Individual
Name
Professor Paul Fitzgerald
Address
Monash Alfred Psychiatry Research Centre (MAPrc): Level 4, 607 St Kilda Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 291095 0
Hospital
Name [1] 291095 0
Alfred Hospital
Address [1] 291095 0
55 Commercial Road
PO Box 315 Prahran
Victoria 3181 Australia
Country [1] 291095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293875 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 293875 0
Ethics committee country [1] 293875 0
Australia
Date submitted for ethics approval [1] 293875 0
22/10/2015
Approval date [1] 293875 0
04/11/2015
Ethics approval number [1] 293875 0
485/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61638 0
Prof Paul Fitzgerald
Address 61638 0
MAPrc Level 4, 607 St Kilda Rd, Melbourne VIC 3004
Country 61638 0
Australia
Phone 61638 0
+ 61 3 9076 6552
Fax 61638 0
+61 3 9076 8545
Email 61638 0
[email protected]
Contact person for public queries
Name 61639 0
Paul Fitzgerald
Address 61639 0
MAPrc Level 4, 607 St Kilda Rd, Melbourne VIC 3004
Country 61639 0
Australia
Phone 61639 0
+ 61 3 9076 6552
Fax 61639 0
+61 3 9076 8545
Email 61639 0
[email protected]
Contact person for scientific queries
Name 61640 0
Paul Fitzgerald
Address 61640 0
MAPrc Level 4, 607 St Kilda Rd, Melbourne VIC 3004
Country 61640 0
Australia
Phone 61640 0
+ 61 3 9076 6552
Fax 61640 0
+61 3 9076 8545
Email 61640 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.