Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

NCT04384965 | Completed

• 1 other identifier: 059/2020
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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

Keywords

depression; transcranial magnetic stimulation; treatment resistance; theta burst stimulation

Outcome Measures

Primary Outcomes (1)

• Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

  Less than or equal to 10

  Up to 10 days (From screening/baseline to end of the acute treatment)

Secondary Outcomes (15)

• Change in HRSD-24

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Response on HRSD-24

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Remission on Patient Health Questionnaire (PHQ-9)

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Response on PHQ-9

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Change in PHQ-9

  Up to 10 days (From screening/baseline to end of the acute treatment)

Study Arms (1)

Accelerated iTBS

EXPERIMENTAL

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.

Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Interventions

MagPro X100 Stimulator, B70 Fluid-Cooled Coil 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.

Accelerated iTBS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

CAMH

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 39443721 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Daniel Blumberger, MD

  CAMH

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

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: May 12, 2020
• Primary Completion: May 18, 2022
• Study Completion: November 1, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CA (1)