An interventional study of Repetitive Transcranial Magnetic Stimulation in Major Depressive Episode and Major Depressive Disorder, sponsored by University of British Columbia. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).
The overarching goal of this trial is to evaluate whether a definite adaptive pragmatic trial would be feasible and establish clear go/no-go criteria as to whether proceeding to such definite trial is feasible. Specific aims include 1) testing the feasibility of recruiting a sample of TRD patients with less strict inclusion and exclusion criteria; 2) comparing different depression and anxiety scales (both clinician-rated and self-rated) and seek input from patients regarding their preferences; 3) seek input from patients with regards to the use of digital phenotyping as a tool to investigate biomarkers as well as engaging in the design of a potential implementation of such biomarker in a future definite trial.
Aim 1. To evaluate the feasibility of a future definite adaptive pragmatic RCT comparing left vs right DLPFC repetitive transcranial magnetic stimulation (rTMS) in TRD.
Hypothesis 1a: Enrollment will be 70% of the planned target over the 1-year recruitment period.
Hypothesis 1b: Retention rate of randomized participants will be ≥70% at the end of the intervention in both groups.
Aim 2. To evaluate patients' preferences regarding information about treatment options when there is no response to allocated treatment.
Hypothesis 2: Patients will prefer to modify treatment when there is no response.
Aim 3. To assess the feasibility of digital phenotyping as an tool to investigate biomarkers in TRD.
Hypothesis 3a: Survey uptake and participation in the study regarding the use of digital phenotyping will be 80% of randomized participants. Hypothesis 3b: Of those survey responders, 75% will indicate they would consent to digital phenotyping in a future definite RCT.
Aim 4. To develop a Bayesian statistical model that continuously updates personalized treatment effect estimates as the trial progresses, and identify the circumstances under which use of the model in a full-scale trial could inform treatment choice as the trial progresses.
Hypothesis 4: The modeling results will identify at least one subgroup for whom early stopping of the definitive trial in that subgroup may be warranted.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
iTBS to the L-DLPFC
Device: Repetitive Transcranial Magnetic Stimulation
1Hz stimulation to the R-DLPFC
Device: Repetitive Transcranial Magnetic Stimulation
rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.
Depression severity
Inventory of Depressive Symptoms (IDS-30-SR); Minimum value per question: 0; Maximum value per question: 3; Total minimum value: 0; Total maximum value: 84; Higher score means worse outcome.
Time frame: one week post treatment
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS); This questionnaire has binary responses (Yes/No). More responses with "Yes" mean worse outcome.
Time frame: one week post treatment
Anxiety severity
Brief Symptom Inventory anxiety subscale (BSI-Anxiety); Minimum value per question: 0 (Not at all); Maximum value per question: 4 (Extremely); Total minimum value: 0; Total maximum value: 24; Higher score means worse outcome.
Time frame: one week post treatment
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of British Columbia