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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00808938

Registration number

NCT00808938

Ethics application status

Date submitted

15/12/2008

Date registered

16/12/2008

Date last updated

13/02/2013

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]

28508

Universal Trial Number (UTN)

Trial acronym

MST

Linked study record

Health condition

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

Treatment Resistant Depression

Condition category

Condition code

Neurological

Epilepsy

Neurological

Other neurological disorders

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Devices - MST

Experimental: Active Treatment -

Treatment: Devices: MST
Magnetic Seizure Therapy

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

MADRS

Timepoint [1]

2 weeks

Secondary outcome [1]

Cognitive Assessment

Timepoint [1]

2 - 6 weeks

Eligibility

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

Sex

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 reason
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

Treatment

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

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2009

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/01/2011

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Alfred Psychiatry Research Centre - Prahran

Recruitment postcode(s) [1]

3181 - Prahran

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

Summary

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

https://clinicaltrials.gov/study/NCT00808938

Trial related presentations / publications

Fitzgerald PB, Hoy KE, Herring SE, Clinton AM, Downey G, Daskalakis ZJ. Pilot study of the clinical and cognitive effects of high-frequency magnetic seizure therapy in major depressive disorder. Depress Anxiety. 2013 Feb;30(2):129-36. doi: 10.1002/da.22005. Epub 2012 Oct 18.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00808938

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00808938