Major Depressive DisorderNCT04384965
Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic
A study testing MagPro X100 Stimulator, B70 Fluid-Cooled Coil in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- MagPro X100 Stimulator, B70 Fluid-Cooled Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- 12 May 2020to 1 Nov 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic
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
- Being tested
- MagPro X100 Stimulator, B70 Fluid-Cooled Coil
- Keywords
- depression, transcranial magnetic stimulation, treatment resistance, theta burst stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro X100 Stimulator, B70 Fluid-Cooled CoilDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Less than or equal to 10
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary outcomes (15)
Change in HRSD-24
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on HRSD-24
50% Reduction in score
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Patient Health Questionnaire (PHQ-9)
Less than or equal to 4
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on PHQ-9
50% Reduction in score
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in PHQ-9
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on General Anxiety Disorder 7 item (GAD-7)
Less than or equal to 4
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on GAD-7
50% Reduction in score
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in GAD-7
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Depression Inventory (BDI-II)
Less than or equal to 12
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on BDI-II
50% Reduction in Score
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on BDI-II
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Scale for Suicidal Ideation (SSI)
Score of 0
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on SSI
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in WHO Disability Assessment Schedule (WHODAS)
changes in scores
Measured: Up to 10 days (From screening/baseline to end of the acute treatment)
Proportion of Patients Maintaining Response During Relapse Prevention
Includes number of treatment days needed and number going on to receive ECT
Measured: 24 weeks (Tapering and Relapse prevention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start12 May 2020
- Primary completion18 May 2022
- Study completion1 Nov 2022
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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Blumberger, Centre for Addiction and Mental Health
- Investigators
- Daniel Blumberger, MD, Principal investigator, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384965
- Sponsor's protocol ID
- 059/2020
- Status last verified
- Feb 2024
- First submitted
- 8 May 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39443721
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04384965
- Acronym / sponsor ID
- 059/2020
- Conditions
- Major Depressive Disorder
- Keywords
- depression, transcranial magnetic stimulation, treatment resistance, theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 12 May 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accelerated iTBS | Experimental | Device: MagPro X100 Stimulator, B70 Fluid-Cooled CoilIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 Stimulator, B70 Fluid-Cooled CoilTreatment 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. | Device | Accelerated iTBS |
Primary outcome
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Less than or equal to 10
15 secondary outcomes
Change in HRSD-24
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on HRSD-24
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Patient Health Questionnaire (PHQ-9)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on PHQ-9
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in PHQ-9
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on General Anxiety Disorder 7 item (GAD-7)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on GAD-7
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in GAD-7
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Depression Inventory (BDI-II)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Response on BDI-II
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on BDI-II
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Remission on Beck Scale for Suicidal Ideation (SSI)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change on SSI
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Change in WHO Disability Assessment Schedule (WHODAS)
Time frame: Up to 10 days (From screening/baseline to end of the acute treatment)
Proportion of Patients Maintaining Response During Relapse Prevention
Time frame: 24 weeks (Tapering and Relapse prevention phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39443721Goodman 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.
Related trials for Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
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.
Daniel Blumberger, 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 Stimulator, B70 Fluid-Cooled Coil in people with Major Depressive Disorder, 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 20 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) (time frame: Up to 10 days (From screening/baseline to end of the acute 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 NCT04384965, 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 20 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.