Accelerated TBS in Late Life Depression

NCT05119699 | Unknown

• 1 other identifier: 070-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-arm, open-label, feasibility trial for the assessment of the clinical effects of a course of accelerated bilateral sequential theta burst stimulation (TBS) for late life depression (LLD). Over approximately 1 year, 30 outpatients at the Centre for Addiction and Mental Health (CAMH) meeting diagnostic criteria for LLD will be recruited and will receive 5 consecutive days (always Monday to Friday) of TBS repetitive transcranial magnetic stimulation (rTMS), administered 8 times daily at approximately 1 hour intervals, with continuous theta-burst stimulation (cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) followed by left DLPFC intermittent theta-burst stimulation (iTBS). Patients will undergo a series of assessments as well as motor threshold testing to determine the appropriate site and strength of stimulation according to standard methods and then begin treatment.

Conditions

Treatment Resistant Depression

Keywords

Treatment Resistant Depression; rTMS; Accelerated TBS; Late Life Depression

Outcome Measures

Primary Outcomes (1)

• Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score

  The investigators will assess the effects of accelerated sequential bilateral TBS based on change on the MADRS using an ANCOVA covarying for baseline differences to measure the change at the final time point for each subject. Higher MADRS scores indicates more severe depression. The overall score ranges from 0 to 60.

  baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment

Secondary Outcomes (4)

• Changes in 17 Item Hamilton Rating Scale for Depression (HDRS-17)

  baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment

• Changes in Beck Depression Inventory (BDI-II)

  baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment

• Changes in Beck Suicide Scale for Suicide Ideation (BSS)

  baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment

• Changes in General Anxiety Disorder-7 (GAD-7)

  baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment

Study Arms (1)

Active rTMS treatment

EXPERIMENTAL

Patients will receive accelerated TBS

Device: MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil

Interventions

MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil DEVICE

Subjects will receive 5 consecutive days (always Monday to Friday) of TBS rTMS, administered 8 times daily at 1 hour intervals. Patients will undergo cTBS of the R DLPFC at 110-120% RMT using bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for a total of 600 pulses over 40 seconds, followed by iTBS of the L DLPFC at 110-120% resting motor threshold (RMT) using bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz with a duty cycle of 2 s on, 8 s off for a total of 600 pulses over 3 min 9 s. Participants will be titrated to 110-120% RMT within the first four treatments to aid with tolerability. If patients tolerate the stimulation well, the target will be 120%. Assessments focused on depressive symptoms will be administered at baseline, after final treatment and four weeks post final treatment.

Active rTMS treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are voluntary and competent to consent to treatment
• are an outpatient
• are ≥60 years old
• have a Mini-International Neuropsychiatric Interview (MINI 6.0) confirmed diagnosis of major depressive disorder (MDD), with a current major depressive episode (MDE)
• have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \> 3 in the current episode or have failed to tolerate two separate trials of an antidepressant
• have a score \> 18 on the Montgomery-Asberg Depression Rating Scale (MADRS)
• have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
• Pass the TMS adult safety screening (TASS) questionnaire

You may not qualify if:

• have a history of substance dependence or abuse within the last 3 months
• have a concomitant major unstable medical illness as determined by one of the study physicians
• have active suicidal intent
• have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
• have current psychotic symptoms
• have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
• have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.
• did not respond to a course of electroconvulsive therapy (ECT) in the current depressive episode
• have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible
• have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.
• 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
• have a implanted electronic device that is currently function such as a defibrillator
• currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
• if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
• non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

RECRUITING

Related Publications (1)

• Hui J, Trevizol AP, Lee HH, Zomorrodi R, Zrenner C, Mulsant BH, Blumberger DM. Effects of Comorbid Anxiety on Treatment Outcomes After Accelerated Theta Burst Stimulation for Late-Life Depression. Am J Geriatr Psychiatry. 2026 Feb;34(2):229-234. doi: 10.1016/j.jagp.2025.09.017. Epub 2025 Sep 20.

  PMID: 41109788 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Alisson Trevizol, MD

  CAMH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Finewax, MSc

CONTACT

416-535-8501; angela.finewax@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-arm, open-label, feasibility trial for the assessment of the clinical effects of a course of accelerated bilateral sequential TBS for LLD

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 15, 2021
• Study Start: October 14, 2021
• Primary Completion: October 14, 2023
• Study Completion: October 14, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)