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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayside Health
ClinicalTrials.gov Identifier:
NCT00808938
First received: December 15, 2008
Last updated: February 11, 2013
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Treatment Resistant Depression
Device: MST
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Use of Magnetic Seizure Therapy for Treatment Resistant Depression

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • MADRS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive Assessment [ Time Frame: 2 - 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment Device: MST
Magnetic Seizure Therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808938

Locations
Australia, Victoria
Alfred Psychiatry Research Centre
Prahran, Victoria, Australia, 3181
Sponsors and Collaborators
Bayside Health
  More Information

No publications provided by Bayside Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayside Health
ClinicalTrials.gov Identifier: NCT00808938     History of Changes
Other Study ID Numbers: 28508
Study First Received: December 15, 2008
Last Updated: February 11, 2013
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014