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Major Depressive DisorderNCT04255784

High Dose Accelerated iTBS for Depression

A study testing Active iTBS in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Active iTBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
2 sitesCanada
Study dates
6 Feb 2020to 24 Jan 2025
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • are outpatients
  • are voluntary and competent to consent to treatment
  • have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single or recurrent
  • are between the ages of 18 and 65
  • have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial of > 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants)
  • have a score > 18 on the HRSD-17 item
Show all 10Show fewer
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  • able to adhere to the treatment schedule
  • Pass the TMS adult safety screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work.

Who cannot join

  • have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • are pregnant
  • have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  • have a MINI 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, that is assessed by a study investigator to be primary and causing greater impairment than MDD
Show all 15Show fewer
  • have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  • have failed a course of ECT in the current episode or previous episode
  • have received rTMS for any previous indication due to the potential compromise of subject blinding
  • 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, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, 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
  • 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
  • clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians
  • currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CAMH

    Toronto, Ontario, M6J1H4

  • University of British Columbia

    Vancouver, British Columbia, V6T2A1

Other trials in Canada

About this study

Official title: A Randomized Sham-Controlled Trial of High-Dosage Accelerated Intermittent Theta Burst rTMS in Major Depression

This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control. Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.

Read the detailed description

Those participants who do not meet the response criterion (50% improvement from baseline on the HRDS-17) at the 4-week follow-up will be offered a second course of treatment, regardless of whether they were in the active or the sham treatment group. The blind will be maintained and no further assessment contributing to the primary or secondary outcomes will occur after the 4-week time point. A different operator will administer the open-label second course of treatment to ensure blinding of operators. The second course of treatment will apply active rTMS using low-frequency (1 Hz) stimulation to the right DLPFC for 600 pulses (10 minutes), 8x daily at 50 minutes (between session and end and start) intervals for 5 days. All those completing the second course of treatment will undergo the same set of clinical assessments during and after the course of treatment on the same schedule as the first course of treatment. The final 4-week follow up assessment from the first course of treatment will serve as the baseline for those that go on to receive the second open label treatment course.

Being tested
Active iTBS, Sham iTBS
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.

  • Active iTBSDevice

    Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30

  • Sham iTBSDevice

    Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30

Study groups in NCT04255784
Study groupRoleWhat they receive
Active iTBSExperimentalAdministered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days. Each session will deliver 1800 pulses of active 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 / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Receives: Device: Active iTBS
Sham iTBSSham comparatorAdministered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 1800 pulses of sham 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 / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
Receives: Device: Sham iTBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

    ITT

    Measured: After 5 treatment days

Secondary outcomes (4)

  1. Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

    ITT

    Measured: one week and four weeks post treatment

  2. Proportion of participants achieving response (50% reduction in HRSD-17) and remission (HRSD-17 <8)

    ITT

    Measured: After 5 treatment days and at 1-week and 4 weeks post-treatment

  3. Change on the Beck Depression Inventory-II (BDI-II)

    ITT

    Measured: After 5 treatment days and at 1-week and 4 weeks post-treatment

  4. Change on the Generalized Anxiety Disorder 7-Item (GAD-7)

    ITT

    Measured: After 5 treatment days and at 1-week 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.

  1. First posted5 Feb 2020
  2. Study start6 Feb 2020
  3. Primary completion24 Jan 2025
  4. Study completion24 Jan 2025

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04255784
Sponsor's protocol ID
109-2019
Status last verified
Jan 2025
First submitted
3 Feb 2020
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goodman MS, Vila-Rodriguez F, Barwick M, Burke MJ, Downar J, Hunter J, Kaster TS, Knyahnytska Y, Kurdyak P, Maunder R, Thorpe K, Trevizol AP, Voineskos D, Zhang W, Blumberger DM. A randomized sham-controlled trial of high-dosage accelerated intermittent theta burst rTMS in major depression: study protocol. BMC Psychiatry. 2024 Jan 8;24(1):28. doi: 10.1186/s12888-023-05470-9.

    PubMed 38191370

Questions about this trial

What is this clinical trial studying?

A study testing Active iTBS in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 2 sites 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 10 inclusion and 15 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) (time frame: After 5 treatment days). 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 NCT04255784, 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 29 Jan 2025.

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