Magnetic Seizure Therapy (MST) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder
Condition: Depressive Disorder; Schizophrenia; Schizoaffective Disorder; Obsessive-Compulsive Disorder
MeSH terms: Seizures; Depression; Depressive Disorder; Schizophrenia; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Psychotic Disorders; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression, and
      is also useful in treatment-refractory cases of schizophrenia and obsessive compulsive
      disorder (OCD). However, its use is limited by significant adverse effects on memory and
      cognition. In addition, ECT cannot be precisely targeted, since it relies on unpredictable
      pathways of electrical conduction through the brain. Magnetic seizure therapy (MST) is
      currently under investigation as a targetable, cognition-sparing alternative to ECT. MST uses
      magnetic fields rather than electrical stimuli for seizure induction, dramatically reducing
      the passage of induced current through undesired brain regions. 10 years of experimental
      studies have established the safety of MST in animal and human subjects. This pilot study
      will investigate whether MST has similar efficacy to ECT, with fewer cognitive side effects,
      in patients with severe depression, schizophrenia, and OCD.
    

Detailed description: 
      Although ECT is effective against severe depression, psychosis, and OCD, it also produces
      significant impairments of autobiographical memory and other cognitive functions. These side
      effects limit the acceptability and tolerability of ECT in many patient populations. They
      also limit the number of treatments that can be administered in a course of ECT, leading to
      high relapse rates once ECT is discontinued. In animal studies, MST has been shown to have
      far fewer adverse cognitive effects than ECT. In small human studies, humans have shown
      faster subjective and objective recovery of orientation after MST than with ECT. However, the
      precise degree of cognitive sparing in MST versus ECT has yet to be established. Likewise,
      the comparative efficacy of MST versus ECT in severe depression, schizophrenia, and OCD
      remains to be seen. The investigators aim to determine whether MST spares autobiographical
      memory and other cognitive functions, while retaining comparable efficacy to that of ECT.

      Objective 1: To compare the efficacy of MST and ECT in treating patients with severe
      depression, schizophrenia, and OCD.

      Hypothesis 1: MST will have equivalent efficacy to ECT on objective measures of mood,
      schizophrenia, and OCD symptoms.

      Objective 2: To compare the effects of MST and ECT on autobiographical memory and other
      cognitive functions in patients with severe depression, schizophrenia, schizoaffective
      disorder and OCD.

      Hypothesis 2: MST will have significantly lower adverse effects on objective measures of
      autobiographical memory and other cognitive functions in patients with severe depression,
      schizophrenia, and OCD.

      Objective 3: To compare the changes in brain function that result from MST and ECT.

      Hypothesis 3: Both MST and ECT will produce changes in functional brain activity consistent
      with antidepressant response, antipsychotic response, and antiobsessive response, along with
      a sparing of cognitive functions.

      The discovery of a viable alternative to ECT, with equivalent efficacy but fewer side
      effects, would have a transformative effect on the treatment of several forms of severe
      mental illness. At present, many patients who could benefit from ECT do not pursue this
      treatment due to concerns about cognitive side effects, as well as the enduring social stigma
      of ECT itself. In addition, many patients who have benefited from ECT are obliged to
      discontinue this effective treatment because of mounting cognitive side effects; high rates
      of relapse then ensue.

      If MST could be shown to spare autobiographical memory and other forms of cognition, many
      more patients would be willing to take advantage of the treatment. They would also be able to
      continue the treatment, when effective, for longer periods. The potential result would be a
      dramatic improvement in the rates of remission and relapse for patients with severe
      depression and other forms of mental illness.
    

Intervention name(s): Magnetic Seizure Therapy (MagPro MST)
Intervention type(s): Device
Intervention description(s): 100% machine output at between 25 and 100 Hz, with coil directed over frontal or vertex brain regions, until adequate seizure achieved. Six treatment sessions, at a frequency of two or three times per week will be administered. If subjects fail to achieve the pre-defined criteria of remission at that point, the dose will be increased to the maximal stimulator output and 3 additional treatment sessions will be provided. This will be repeated a total of 5 times (i.e., maximum treatment number is 24). 24 treatments is typically longer that a conventional ECT treatment course. However, evidence does suggest that longer treatment courses may be needed with MST, particularly in more treatment resistant psychiatric conditions such as OCD and schizophrenia.
Other intervention name(s): MagPro MST (Tonica Elektronik A/S, Denmark)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Magnetic seizure therapy; Treatment resistance; Open-label trial; Treatment resistant depression; Treatment resistant schizophrenia; Treatment resistant obsessive-compulsive disorder