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Major DepressionNCT02998580

Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

A study testing LFR followed by HFL and cTBS followed by iTBS in people with Major Depression, run by Centre for Addiction and Mental Health at 1 site 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 conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Major Depression
What is being tested?
LFR followed by HFL and cTBS followed by iTBS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteCanada
Study dates
Dec 2016to 24 Apr 2020
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 an outpatient
  • are ≥60 years old
  • have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current 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 > 17 on the MADRS
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
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  • have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work
  • Pass the TMS adult safety screening (TASS) questionnaire
  • Are able to have an MRI

Who cannot join

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness 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, and 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 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

  • CAMH

    Toronto, Ontario, M6J1H4

Other trials in Canada

About this study

This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices 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 bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

Being tested
LFR followed by HFL, cTBS followed by iTBS
Keywords
late-life depression, treatment resistance
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • LFR followed by HFLDevice

    Magventure Cool B70 Coil with RX100 Stimulator

  • cTBS followed by iTBSDevice

    Magventure Cool B70 Coil with RX100 Stimulator

Study groups in NCT02998580
Study groupRoleWhat they receive
Convential Sequential Bilateral rTMSActive comparatorLFR followed by HFL. 1 Hz stimulation of the right DLPFC for 600 pulses followed by 10 Hz stimulation of the left DLPFC for 3000 pulses (4 seconds on 26 seconds off for 75 trains). Treatment will occur 5 times per week for 4 to 6 weeks.
Receives: Device: LFR followed by HFL
Bilateral Theta Burst StimulationExperimentalcTBS followed by iTBS. continuous theta burst stimulation (cTBS) of the right DLPFC for 600 pulses followed by intermittent theta burst stimulation (iTBS) of the left DLPFC for 600 pulses. Treatment will occur 5 times per week for 4 to 6 weeks.
Receives: Device: cTBS followed by iTBS

What is being measured

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

  1. Change on the Montgomery Asberg Depression Rating Scale (MADRS)

    Change from baseline to week 4 or 6 endpoint

    Measured: After 4 or 6 weeks

Secondary outcomes (1)

  1. Remission on the MADRS

    Score less than or equal to 10

    Measured: After 4 or 6 weeks

Timeline

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

  1. First posted20 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion24 Apr 2020
  4. Study completion24 Apr 2020

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
Single blind
Who is masked
Outcomes assessor
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02998580
Sponsor's protocol ID
076-2016
Status last verified
Feb 2024
First submitted
16 Dec 2016
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: The study protocol and statistical analysis plan will be made available. Individual patient data will be made available once all primary and secondary analyses have been conducted by the study team.

Publications

  • Adler E, Blumberger DM, Chen X, Lee HH, Nestor SM, Downar J, Mulsant B, Rajji TK, Noda Y, Daskalakis ZJ, Kaster TS. Trajectories of response to bilateral rTMS in late-life depression. Brain Stimul. 2025 Nov-Dec;18(6):2067-2074. doi: 10.1016/j.brs.2025.10.020. Epub 2025 Nov 1.

    PubMed 41183728

  • Lee HH, Goke K, Wathra RA, Mulsant B, Trevizol AP, Downar J, McClintock SM, Nestor SM, Noda Y, Rajji TK, Daskalakis ZJ, Blumberger DM. Clinical effects and correlates of standard rTMS and theta burst stimulation (TBS) on suicidal ideation in late-life depression. Eur Psychiatry. 2025 Jun 27;68(1):e92. doi: 10.1192/j.eurpsy.2025.10049.

    PubMed 40574540

  • 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

  • Goke K, McClintock SM, Mah L, Rajji TK, Lee HH, Nestor SM, Downar J, Noda Y, Daskalakis ZJ, Mulsant BH, Blumberger DM. Cognitive Outcomes After Transcranial Magnetic Stimulation for the Treatment of Late-Life Depression: Resultats cognitifs apres la stimulation magnetique transcranienne pour le traitement de la depression chez les personnes agees. Can J Psychiatry. 2026 Jul;71(7):498-508. doi: 10.1177/07067437251315515. Epub 2025 Jan 29.

    PubMed 39881587

  • Goke K, Trevizol AP, Ma C, Mah L, Rajji TK, Daskalakis ZJ, Downar J, McClintock SM, Nestor SM, Noda Y, Mulsant BH, Blumberger DM. Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of late-life depression. Psychiatry Res. 2024 Apr;334:115822. doi: 10.1016/j.psychres.2024.115822. Epub 2024 Feb 29.

    PubMed 38452496

  • Blumberger DM, Mulsant BH, Thorpe KE, McClintock SM, Konstantinou GN, Lee HH, Nestor SM, Noda Y, Rajji TK, Trevizol AP, Vila-Rodriguez F, Daskalakis ZJ, Downar J. Effectiveness of Standard Sequential Bilateral Repetitive Transcranial Magnetic Stimulation vs Bilateral Theta Burst Stimulation in Older Adults With Depression: The FOUR-D Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2022 Nov 1;79(11):1065-1073. doi: 10.1001/jamapsychiatry.2022.2862.

    PubMed 36129719

Questions about this trial

What is this clinical trial studying?

A study testing LFR followed by HFL and cTBS followed by iTBS in people with Major 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 9 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: 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?

Change on the Montgomery Asberg Depression Rating Scale (MADRS) (time frame: After 4 or 6 weeks). 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 NCT02998580, which also lists 6 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 20 Feb 2024.

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