A Pilot Study of the Use of Magnetic Seizure Therapy for Depression
Condition: Treatment Resistant Depression
MeSH terms: Seizures; Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

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.
    


Intervention name(s): MST
Intervention type(s): Device
Intervention description(s): Magnetic Seizure Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment