Treatment Resistant DepressionNCT05119699
Accelerated TBS in Late Life Depression
A study testing MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil in people with Treatment Resistant Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 14 Oct 2021to 14 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Angela Finewax, MSc, 416-535-8501 ext. 33797, angela.finewax@camh.ca
About this study
Official title: An Open-label Trial on Accelerated Sequential Bilateral Theta Burst Repetitive Transcranial Magnetic Stimulation in Treatment-resistant Late-life Depression
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.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an evidenced based treatment for medically refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when medications have failed. In the most recent generation of randomized controlled trials, rTMS consistently achieves response rates of 50-55% and remission rates of 30-35% in medically refractory MDD patients. rTMS has been shown to be effective and well tolerated for depression in younger and older adults. However, early rTMS studies with older adults were limited by suboptimal stimulation parameters, small sample sizes and insufficient treatment durations. The optimal parameters for rTMS are still in the process of being established, however the most widely-used rTMS protocols apply excitatory, 10 Hz stimulation to the left DLPFC; high frequency left (HFL) or inhibitory, 1 Hz stimulation to the right DLPFC; low frequency right (LFR), or both. Taken together with the reported findings of several other groups, results suggest that accelerated rTMS may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30 day courses. However, all of these studies were small, open-label case series, focused on younger adults.
- Conditions
- Treatment Resistant Depression
- Being tested
- MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil
- Keywords
- Treatment Resistant Depression, rTMS, Accelerated TBS, Late Life Depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS treatment | Experimental | Patients will receive accelerated TBS Receives: Device: MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The investigators will assess the effects of accelerated sequential bilateral TBS based on change on the HDRS-17 using an ANCOVA covarying for baseline differences to measure the change at the final time point for each subject. Higher HDRS-17 scores indicates more severe depression. The overall score ranges from 0 to 53.
Measured: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Changes in Beck Depression Inventory (BDI-II)
The investigators will assess the effects of accelerated sequential bilateral TBS based on change on the BDI-II using an ANCOVA covarying for baseline differences to measure the change at the final time point for each subject. Higher BDI-II scores indicates more severe depression. The overall score ranges from 0 to 63.
Measured: 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)
The investigators will assess the effects of accelerated sequential bilateral TBS based on change on the BSS using an ANCOVA covarying for baseline differences to measure the change at the final time point for each subject. Higher BSS scores indicates more severe suicidality. The overall score ranges from 0 to 38.
Measured: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Changes in General Anxiety Disorder-7 (GAD-7)
The investigators will assess the effects of accelerated sequential bilateral TBS based on change on the GAD-7 using an ANCOVA covarying for baseline differences to measure the change at the final time point for each subject. Higher GAD-7 scores indicates more severe anxiety. The overall score ranges from 0 to 21.
Measured: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start14 Oct 2021
- Primary completion14 Oct 2023 (estimated)
- Study completion14 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisson Trevizol, MD, Principal investigator, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119699
- Sponsor's protocol ID
- 070-2021
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41109788
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Trial on Accelerated Sequential Bilateral Theta Burst Repetitive Transcranial Magnetic Stimulation in Treatment-resistant Late-life Depression
- ClinicalTrials.gov ID
- NCT05119699
- Acronym / sponsor ID
- 070-2021
- Conditions
- Treatment Resistant Depression
- Keywords
- Treatment Resistant Depression, rTMS, Accelerated TBS, Late Life Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 14 Oct 2023 (estimated)
- Study completion
- 14 Oct 2023 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an evidenced based treatment for medically refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. Dozens of studies and several meta-analyses over the last 15 years have shown that rTMS of the dorsolateral prefrontal cortex (DLPFC) produces statistically significant improvements in MDD, even when medications have failed. In the most recent generation of randomized controlled trials, rTMS consistently achieves response rates of 50-55% and remission rates of 30-35% in medically refractory MDD patients. rTMS has been shown to be effective and well tolerated for depression in younger and older adults. However, early rTMS studies with older adults were limited by suboptimal stimulation parameters, small sample sizes and insufficient treatment durations. The optimal parameters for rTMS are still in the process of being established, however the most widely-used rTMS protocols apply excitatory, 10 Hz stimulation to the left DLPFC; high frequency left (HFL) or inhibitory, 1 Hz stimulation to the right DLPFC; low frequency right (LFR), or both. Taken together with the reported findings of several other groups, results suggest that accelerated rTMS may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30 day courses. However, all of these studies were small, open-label case series, focused on younger adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Active rTMS treatment | Experimental | Device: MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coilPatients will receive accelerated TBS |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coilSubjects 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. | Device | Active rTMS treatment |
Primary outcome
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
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.
4 secondary outcomes
Changes in 17 Item Hamilton Rating Scale for Depression (HDRS-17)
Time frame: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Changes in Beck Depression Inventory (BDI-II)
Time frame: 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)
Time frame: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Changes in General Anxiety Disorder-7 (GAD-7)
Time frame: baseline, last day of treatment (day 5, after the final treatment) and 4 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 41109788Hui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisson Trevizol, MD principal investigator
CAMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro X100/R30 stimulator equipped with the B70 fluid-cooled coil in people with Treatment Resistant Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela Finewax, MSc (416-535-8501 ext. 33797, angela.finewax@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.