Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

NCT ID: NCT04384965

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-12
• Study Completion Date: 2022-11-01

Brief Summary

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Accelerated iTBS

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.

Group Type: EXPERIMENTAL

MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Intervention Type: DEVICE

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.

Interventions

MagPro X100 Stimulator, B70 Fluid-Cooled Coil

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Daniel Blumberger

Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Blumberger, MD

Role: PRINCIPAL_INVESTIGATOR

CAMH

Locations

CAMH

Toronto, Ontario, Canada

Countries

Canada

References

Goodman MS, Trevizol AP, Konstantinou GN, Boivin-Lafleur D, Brender R, Downar J, Kaster TS, Knyahnytska Y, Vila-Rodriguez F, Voineskos D, Daskalakis ZJ, Blumberger DM. Extended course accelerated intermittent theta burst stimulation as a substitute for depressed patients needing electroconvulsive therapy. Neuropsychopharmacology. 2025 Mar;50(4):685-694. doi: 10.1038/s41386-024-02007-w. Epub 2024 Oct 23.

Reference Type: DERIVED

PMID: 39443721 (View on PubMed)

Other Identifiers

059/2020

Identifier Type: -

Identifier Source: org_study_id