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A Pilot Study of the Use of Magnetic Seizure Therapy for Depression (MST)

Primary Purpose

Treatment Resistant Depression

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
MST
Sponsored by
Bayside Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Alfred Psychiatry Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Treatment

Arm Description

Outcomes

Primary Outcome Measures

MADRS

Secondary Outcome Measures

Cognitive Assessment

Full Information

First Posted
December 15, 2008
Last Updated
February 11, 2013
Sponsor
Bayside Health
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1. Study Identification

Unique Protocol Identification Number
NCT00808938
Brief Title
A Pilot Study of the Use of Magnetic Seizure Therapy for Depression
Acronym
MST
Official Title
A Pilot Study of the Use of Magnetic Seizure Therapy for Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MST
Intervention Description
Magnetic Seizure Therapy
Primary Outcome Measure Information:
Title
MADRS
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Cognitive Assessment
Time Frame
2 - 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a DSM-IV diagnosis of a major depressive episode Are referred for or an outpatient course of ECT at the Alfred Hospital Age 18-75 Have a Montgomery-Asberg Depression Rating Scale (MADRS) score of > 25 (moderate - severe depression) Demonstration of capacity to give informed consent: this will be assessed by the study psychiatrist as well as the patient's primary treating psychiatrist. Exclusion Criteria: Have an unstable medical condition, or neurological disorder or are currently pregnant or lactating. Patients not considered sufficiently well to undergo general anaesthesia for any reason Patients with cardiac pacemakers, cochlear implants or other implanted electronic devices. Patients with non-electric metallic implants will also be excluded. Significant concurrent axis 1 or 11 psychiatric comorbidity.
Facility Information:
Facility Name
Alfred Psychiatry Research Centre
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23080404
Citation
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.
Results Reference
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A Pilot Study of the Use of Magnetic Seizure Therapy for Depression

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