Magnetic Seizure Therapy (MST) for Treatment Resistant Depression, Schizophrenia, and Obsessive Compulsive Disorder

NCT01596608 | Completed DMC

• 1 other identifier: 145-2010
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder; Schizophrenia; Schizoaffective Disorder; Obsessive-Compulsive Disorder

Keywords

Magnetic seizure therapy; Treatment resistance; Open-label trial; Treatment resistant depression; Treatment resistant schizophrenia; Treatment resistant obsessive-compulsive disorder

Outcome Measures

Primary Outcomes (5)

• Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS)

  i) The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms. ii) The Y-BOCS is a clinician-rated scale used to assess the severity of OCD symptoms. iii) The BPRS is a clinician-administered scale used to assess the severity of various psychiatric symptoms, such as depression, anxiety, hallucinations, and delusions. In this study, it will be used with participants diagnosed with schizophrenia.

  Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks

• Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS

  Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment

• Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS

  Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment

• Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS

  Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment

• Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS

  Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment

Secondary Outcomes (4)

• Cognitive Functioning

  Change from baseline in cognitive functioning at date of symptom remission or at date of 24th treatment, whichever comes first, assessed up to 12 weeks

• Cognitive Functioning

  Change from baseline in cognitive functioning at 6 months after final treatment

• Neuroimaging (brain structure and activity)

  Changes from baseline in brain structure and activity within 48 hours after final treatment

• Neuroimaging (brain structure and activity)

  Changes from baseline in brain structure and activity at 6 months after final treatment

Study Arms (1)

Magnetic Seizure Therapy

EXPERIMENTAL

Device: Magnetic Seizure Therapy (MagPro MST)

Interventions

Magnetic Seizure Therapy (MagPro MST) DEVICE

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.

Also known as: MagPro MST (Tonica Elektronik A/S, Denmark)

Magnetic Seizure Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18 to 85
• DSM-IV diagnosis of major depressive episode with or without psychotic features in the context of MDD or bipolar disorder; OCD or Schizophrenia
• item HRSD score of ≥ 21 (for depression subjects)
• item BPRS score of ≥ 37 (for schizophrenia subjects)
• Y-BOCS score of ≥ 16 (for OCD subjects)
• demonstrate capacity to give informed consent
• are a Canadian resident

You may not qualify if:

• have an unstable medical and/or neurological condition
• are currently pregnant or lactating
• are not considered sufficiently well to undergo general anesthesia for any reason
• have a cardiac pacemaker, cochlear implant, implanted electronic device or non-electric metallic implant
• are taking a benzodiazepine at a dose greater than lorazepam 2mg or equivalent
• are taking any non-benzodiazepine anticonvulsant
• have active substance misuse or dependence within the past 3 months
• have a current diagnosis of delirium, dementia or another cognitive disorder secondary to a general medical condition
• have a co-morbid borderline personality disorder and/or antisocial personality disorder
• have had a history of any suicide attempts in the past 6 months

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (4)

• Tang VM, Blumberger DM, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Continuation Magnetic Seizure Therapy for Treatment-Resistant Unipolar or Bipolar Depression. J Clin Psychiatry. 2021 Oct 19;82(6):20m13677. doi: 10.4088/JCP.20m13677.

  PMID: 34670025 DERIVED

• Weissman CR, Blumberger DM, Dimitrova J, Throop A, Voineskos D, Downar J, Mulsant BH, Rajji TK, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy for Suicidality in Treatment-Resistant Depression. JAMA Netw Open. 2020 Aug 3;3(8):e207434. doi: 10.1001/jamanetworkopen.2020.7434.

  PMID: 32809030 DERIVED

• Tang VM, Blumberger DM, Dimitrova J, Throop A, McClintock SM, Voineskos D, Downar J, Knyahnytska Y, Mulsant BH, Fitzgerald PB, Daskalakis ZJ. Magnetic seizure therapy is efficacious and well tolerated for treatment-resistant bipolar depression: an open-label clinical trial. J Psychiatry Neurosci. 2020 Sep 1;45(5):313-321. doi: 10.1503/jpn.190098.

  PMID: 31922372 DERIVED

• Tang VM, Blumberger DM, McClintock SM, Kaster TS, Rajji TK, Downar J, Fitzgerald PB, Daskalakis ZJ. Magnetic Seizure Therapy in Treatment-Resistant Schizophrenia: A Pilot Study. Front Psychiatry. 2018 Jan 16;8:310. doi: 10.3389/fpsyt.2017.00310. eCollection 2017.

  PMID: 29387022 DERIVED

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

MeSH Terms

Conditions

Depressive Disorder; Schizophrenia; Psychotic Disorders; Obsessive-Compulsive Disorder; Depressive Disorder, Treatment-Resistant; Schizophrenia, Treatment-Resistant

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Anxiety Disorders

Study Officials

• Z. Jeffrey Daskalakis, MD, PhD.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Temerty Centre for Therapeutic Brain Intervention

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 11, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

CA (1)