Recruiting

Accelerated TBS

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT05119699

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05119699

Start date

Oct 14, 2021

Status verified date

Feb, 2023

Completion date

Oct 14, 2023

Anticipated

Primary completion date

Oct 14, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are voluntary and competent to consent to treatment
2. are an outpatient
3. are ≥60 years old
4. have a Mini-International Neuropsychiatric Interview (MINI 6.0) confirmed diagnosis of major depressive disorder (MDD), with a current major depressive episode (MDE)
5. 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
6. have a score > 18 on the Montgomery-Asberg Depression Rating Scale (MADRS)
7. have had no increase or initiation of any antidepressant or antipsychotic medication in the 4 weeks prior to screening
8. Pass the TMS adult safety screening (TASS) questionnaire

Exclusion Criteria:

1. have a history of substance dependence or abuse within the last 3 months
2. have a concomitant major unstable medical illness as determined by one of the study physicians
3. have active suicidal intent
4. have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
5. have current psychotic symptoms
6. have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary. One of these comorbidities will not be exclusionary if they are not deemed to be primary.
7. have a diagnosis of any personality disorder as assessed by a study investigator to be primary and causing greater impairment than MDD
8. have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.
9. did not respond to a course of electroconvulsive therapy (ECT) in the current depressive episode
10. have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible
11. have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.
12. 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
13. have a implanted electronic device that is currently function such as a defibrillator
14. currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
15. 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
16. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active rTMS treatment

Patients will receive accelerated TBS

Interventions

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

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.

Primary outcome measure

  • Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H4

Contacts

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Feb 8, 2023

Last verified

Feb, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2023-02-08.