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Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Study type

Interventional

Funder types

Other

Identifiers

NCT04384965
059/2020

Details and patient eligibility

About

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.

Enrollment

176 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

176 participants in 1 patient group

Accelerated iTBS
Experimental group
Description:
In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score \< to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.
Treatment:
Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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