Efficacy of Convulsive Therapies for Bipolar Depression

NCT03641300 | Completed

• 1 other identifier: 015-2018
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.

Conditions

Bipolar Disorder; Bipolar Depression; Bipolar I Disorder; Bipolar II Disorder

Keywords

Magnetic Seizure Therapy; Electroconvulsive Therapy; Bipolar Disorder; Depression; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• Remission (score </= 10) on the Hamilton Rating Scale for Depression - 24 (HRSD-24)

  Hamilton Rating Scale for Depression (24-item version): * This scale is used to quantify the severity of symptoms of depression * Scale range: 0-76 (total score) * Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) * Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

  Greater than 8 treatments (2.5 weeks)

• Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)

  Autobiographical Memory Test: \- Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.

  Greater than 8 treatments (2.5 weeks)

Secondary Outcomes (2)

• Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)

  7 weeks

• Number of self-reported and clinical-reported adverse events

  Up to 7 weeks

Study Arms (2)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

MST treatments will be administered using the MagPro MST with Cool TwinCoil.

Device: Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT)

ACTIVE COMPARATOR

ECT treatments will be administered using the MECTA spECTrum 5000Q or MECTA Sigma

Device: Electroconvulsive Therapy (ECT)

Interventions

Magnetic Seizure Therapy (MST) DEVICE

MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds). This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.

Also known as: MST

Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT) DEVICE

In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes

Also known as: ECT

Electroconvulsive Therapy (ECT)

Eligibility Criteria

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

You may qualify if:

• Patients will be included if they:
• are inpatients or outpatients;
• are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
• have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic Bipolar Disorder (Type I or II)
• are 18 years of age or older
• have a baseline HRSD-24 score \> 21;
• are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
• are agreeable to keeping their current antidepressant treatment constant during the intervention;
• are likely able to adhere to the intervention schedule;
• meet the MST safety criteria;
• If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.

You may not qualify if:

• Patients will be excluded if they:
• have a history of MINI diagnosis of substance dependence or abuse within the past three months;
• have a concomitant major unstable medical illness;
• are pregnant or intend to get pregnant during the study;
• have a MINI diagnosis of any primary psychotic disorder
• have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
• have probable dementia based on study investigator assessment;
• have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
• present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
• have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
• require a benzodiazepine with a dose greater than lorazepam 2 mg/day (or equivalent benzodiazepine) or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
• are unable to communicate in English fluently enough to complete the neuropsychological tests;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
• These eligibility criteria are congruent with the criteria that have been used in the major ECT trials conducted during the past decade;
• elevated mood, defined as a score of 20 or higher on the Young Mania Rating Scale (YMRS).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• University of British Columbia: collaborator
• Ontario Shores Centre for Mental Health Sciences: collaborator
• Brain Canada: collaborator

Study Sites (3)

UBC Hospital, University of British Columbia (UBC)

Vancouver, British Columbia, V6T2A1, Canada

Location

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, L1N 5S9, Canada

Location

Related Publications (1)

• Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.

  PMID: 34131914 DERIVED

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital

MeSH Terms

Conditions

Bipolar Disorder; Depression; Suicidal Ideation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• Daniel Blumberger, MD, MSc

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized into the study using a permuted block method with a random number generator. The study statistician will prepare the randomization scheme. The block size will be fixed and study personnel will be blinded to the randomization block size
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Model Details: The study is a randomized, double blind, parallel-group clinical trial with two treatment arms conducted at three academic institutions: the Temerty Centre for Therapeutic Brain Intervention based at CAMH in Toronto, ON; the Ontario Shores Centre for Mental Health Sciences in Whitby, Ontario; and UBC Hospital based at the University of British Columbia in Vancouver, BC. CAMH aims to recruit 40 participants. Parkwood Institute and UBC Hospital aim to recruit 30 participants each.

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 22, 2018
• Study Start: September 21, 2018
• Primary Completion: March 4, 2024
• Study Completion: August 9, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

CA (3)