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Major Depressive DisorderHFL vs TBSNCT01887782

Randomized Controlled Trial of Conventional vs Theta Burst rTMS

A study testing HFL rTMS and iTBS in people with Major Depressive Disorder, 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

This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. 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?
HFL rTMS and iTBS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
3 sitesCanada
Study dates
Sep 2013to Oct 2016
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

  • outpatients
  • voluntary and competent to consent
  • Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single, recurrent
  • between ages 18-65
  • 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 been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  • have a score of ≥ 18 on the HAMD-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 history 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 diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, 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

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

Official title: A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder

This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.

Being tested
HFL rTMS, iTBS
Keywords
depression, magnetic, brain stimulation, treatment-resistant
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.

  • HFL rTMSDevice

    Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

  • iTBSDevice

    Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Study groups in NCT01887782
Study groupRoleWhat they receive
HFL rTMSExperimentalHigh Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
Receives: Device: HFL rTMS
iTBSActive comparatorintermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
Receives: Device: iTBS

What is being measured

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

  1. HAM-D17 score

    Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.

    Measured: baseline, after each 5 treatment sessions, and 1, 4, and 12 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 posted27 Jun 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJul 2016
  4. Study completionOct 2016

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887782
Sponsor's protocol ID
179/2012
Acronym
HFL vs TBS
Status last verified
Jan 2017
First submitted
25 Jun 2013
Last updated
30 Jan 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Individual patient level data will be shared once the investigators have completed all proposed analyses from the data set.

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

  • Kaster TS, Dai Y, Vila-Rodriguez F, Downar J, Daskalakis ZJ, Blumberger DM, Rhee TG. Efficacy of intranasal esketamine versus rTMS for treatment-resistant depression: analysis of individual participant data from two clinical trials. EClinicalMedicine. 2025 Oct 30;90:103609. doi: 10.1016/j.eclinm.2025.103609. eCollection 2025 Dec.

    PubMed 41245530

  • 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

  • Trevizol AP, Downar J, Vila-Rodriguez F, Thorpe KE, Daskalakis ZJ, Blumberger DM. Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial. EClinicalMedicine. 2020 Apr 30;22:100349. doi: 10.1016/j.eclinm.2020.100349. eCollection 2020 May.

    PubMed 32382720

  • Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.

    PubMed 31668646

  • Hsu JH, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM. Impact of prior treatment on remission with intermittent theta burst versus high-frequency repetitive transcranial magnetic stimulation in treatment resistant depression. Brain Stimul. 2019 Nov-Dec;12(6):1553-1555. doi: 10.1016/j.brs.2019.07.011. Epub 2019 Jul 17.

    PubMed 31350213

  • Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15.

    PubMed 30764649

  • Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.

    PubMed 30425640

  • Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

    PubMed 29726344

Questions about this trial

What is this clinical trial studying?

A study testing HFL rTMS and iTBS in people with Major Depressive Disorder, 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 6 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 30 Jan 2017. 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?

HAM-D17 score (time frame: baseline, after each 5 treatment sessions, and 1, 4, and 12 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 NCT01887782, which also lists 9 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 30 Jan 2017.

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