Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

Centre for Addiction and Mental Health176 enrolled

Overview

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

176

Conditions

Major Depressive Disorder

Interventions

MagPro X100 Stimulator, B70 Fluid-Cooled CoilDEVICE

Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \~3 minutes) at a target of 110% of the subject's resting MT.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have unipolar depressive episode based on the MINI with or without psychotic symptoms * Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of a consultant brain stimulation psychiatrist * Are over the age of 18 * Pass the TMS adult safety screening (TASS) questionnaire * Are voluntary and competent to consent to treatment Exclusion Criteria: * Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month * Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder * Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes * 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 * currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy * Lack of response to accelerated course of iTBS or rTMS in the past

Locations (1)

CAMH

Toronto, Ontario, Canada