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DepressionCARTBINDNCT02729792

Canadian rTMS Treatment and Biomarker Network in Depression Trial

A study testing rTMS in people with Depression, run by Centre for Addiction and Mental Health at 3 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

Repetitive transcranial magnetic stimulation (rTMS) is an emerging treatment for medically refractory major depressive disorder (MDD). rTMS involves direct stimulation of cortical neurons using externally applied, powerful, focused magnetic field pulses. Read more about this study

Who is it for?
Ages 18 to 59 years
Conditions the study is for
Depression
What is being tested?
rTMS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
3 sitesCanada
Study dates
Mar 2016to 30 May 2018
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 59 years
  • All sexes
  • No healthy volunteers
  • 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 59
  • 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 105,106 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, 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

3 sites in 1 country.

Canada3 sites

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H4

  • Non-Invasive Neurostimulation Therapies Centre, University of British Columbia

    Vancouver, British Columbia, V6T 2A1

Other trials in Canada

About this study

Repetitive transcranial magnetic stimulation (rTMS) is an emerging 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. However, other possible targets may also yield improvement in symptoms.

In an attempt to enhance the therapeutic efficacy of current interventions for TRD, attention has turned to identifying domain-specific biomarkers in hopes of ultimately individualizing and predicting treatment response. Unfortunately, the precise nature of this relationship is less than clear, as reflected by the fact that even now there are no established biomarkers that are used routinely in clinical practice to aid in diagnosis. This study also seeks to examine a comprehensive suite of biomarker measurements (MRI, neurophysiology, and genomics/proteomics) before and after rTMS treatment.

Read the detailed description

rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression (TRD), using focused magnetic field pulses to stimulate brain regions involved in emotion regulation, safely and non-invasively. Though rTMS is often effective where medications or therapy fail, it requires a series of lengthy (~30-40 min) treatment sessions. A new form of rTMS called theta burst stimulation (TBS) has been shown to have greater effects on neural activity than conventional stimulation, despite requiring as little as 40 s of stimulation. The purpose of this study is to assess the efficacy and tolerability of an accelerated TBS protocol, administered 2 times a day in patients with TRD. In addition, the investigators aim to identify candidate biomarkers from a multimodal suite of neuroimaging, neurophysiologic and molecular measures that are predictors and correlates of response to rTMS treatment.

Conditions
Depression
Being tested
rTMS
Keywords
depression, treatment resistance, biomarkers, repetitive transcranial magnetic stimulation
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMSDevice

    intermittent theta burst stimulation (iTBS)

Study groups in NCT02729792
Study groupRoleWhat they receive
Single site rTMSExperimentalEach treatment session will consist of: 1200 pulses of iTBS over a posterior target location followed by a 60 minute interval, then 1200 pulses of iTBS over an anterior target location.
Receives: Device: rTMS
Dual site rTMSActive comparatorEach treatment session will consist of: 600 pulses of iTBS over the posterior target, followed immediately by 600 pulses of iTBS over the anterior target location followed by a 60 minute interval, then 600 pulses of iTBS over the posterior target, followed immediately by 600 pulses of iTBS over the anterior target location.
Receives: Device: rTMS

What is being measured

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

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

    Change from baseline to 10 days

    Measured: 10 days

Secondary outcomes (1)

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

    Change from baseline to 30 days

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion23 Feb 2018
  4. Study completion30 May 2018

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02729792
Sponsor's protocol ID
052-2015
Acronym
CARTBIND
Status last verified
Jul 2018
First submitted
29 Mar 2016
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Gregory E, Siddiqi SH, Fox MD, Blumberger DM, Downar J, Daskalakis ZJ, Dunlop K, Vila-Rodriguez F. Proximity to an SGC-DLPFC individualized functional target and electric-field modeling do not predict clinical outcomes of rTMS for treatment-resistant depression. Brain Stimul. 2026 Sep-Oct;19(5):103173. doi: 10.1016/j.brs.2026.103173. Epub 2026 Jul 25.

    PubMed 42501968

  • Chen X, Blumberger DM, Yan CG, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Kaster TS. Crosswalk between HRSD and MADRS outcomes for rTMS in patients with depression. BMJ Ment Health. 2025 Mar 28;28(1):e301451. doi: 10.1136/bmjment-2024-301451.

    PubMed 40154967

  • Zapf L, Kaster TS, Vila-Rodriguez F, Daskalakis ZJ, Downar J, Blumberger DM. The effect of once-daily vs. twice-daily intermittent theta burst stimulation on suicidal ideation in treatment-resistant depression. Eur Arch Psychiatry Clin Neurosci. 2025 Sep;275(6):1787-1798. doi: 10.1007/s00406-024-01929-2. Epub 2024 Nov 15.

    PubMed 39545967

  • Kaster TS, Downar J, Vila-Rodriguez F, Baribeau DA, Thorpe KE, Daskalakis ZJ, Blumberger DM. Differential symptom cluster responses to repetitive transcranial magnetic stimulation treatment in depression. EClinicalMedicine. 2022 Dec 2;55:101765. doi: 10.1016/j.eclinm.2022.101765. eCollection 2023 Jan.

    PubMed 36483268

  • Blumberger DM, Vila-Rodriguez F, Wang W, Knyahnytska Y, Butterfield M, Noda Y, Yariv S, Isserles M, Voineskos D, Ainsworth NJ, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. A randomized sham controlled comparison of once vs twice-daily intermittent theta burst stimulation in depression: A Canadian rTMS treatment and biomarker network in depression (CARTBIND) study. Brain Stimul. 2021 Nov-Dec;14(6):1447-1455. doi: 10.1016/j.brs.2021.09.003. Epub 2021 Sep 21.

    PubMed 34560319

Questions about this trial

What is this clinical trial studying?

A study testing rTMS in people with Depression, run by Centre for Addiction and Mental Health at 3 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

17-item Hamilton Rating Scale for Depression (HRSD-17) Change (time frame: 10 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 NCT02729792, which also lists 5 linked publications.

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 26 Jul 2018.

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