Major Depressive EpisodePORTNCT05028738
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
A study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Episode and Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode, Major Depressive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2021to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are outpatients;
- are voluntary and competent to consent to treatment;
- are ≥ 18 years;
- have a score ≥ 26 on the IDS-30-SR;
- 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
Who cannot join
- have active suicidal intent;
- are pregnant;
- have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
- have a concomitant major unstable medical illness;
- have any significant form of dementia or any history of epilepsy;
- have any 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;
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- 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;
- If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication;
- have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
- have a 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
Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia, V6T 2A1
About this study
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).
Read the detailed description
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.
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- Pragmatic, Patient-oriented research, TMS, Treatment-resistant depression, Transcranial Magnetic Stimulation, rTMS
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) | Active comparator | iTBS to the L-DLPFC Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Low Frequency Right (LFR) | Active comparator | 1Hz stimulation to the R-DLPFC Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week post treatment
Secondary outcomes (2)
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS); This questionnaire has binary responses (Yes/No). More responses with "Yes" mean worse outcome.
Measured: 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.
Measured: one week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start11 Oct 2021
- Primary completion1 Aug 2026
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Two-arm, randomized feasibility trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA, University of British Columbia
- Investigators
- Fidel Vila-Rodriguez, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028738
- Sponsor's protocol ID
- H17-00161
- Acronym
- PORT
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2021
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
- ClinicalTrials.gov ID
- NCT05028738
- Acronym / sponsor ID
- PORT / H17-00161
- Keywords
- Pragmatic, Patient-oriented research, TMS, Treatment-resistant depression, Transcranial Magnetic Stimulation, rTMS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, randomized feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Intermittent Theta Burst Stimulation (iTBS) | Active comparator | Device: Repetitive Transcranial Magnetic StimulationiTBS to the L-DLPFC |
| Low Frequency Right (LFR) | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation1Hz stimulation to the R-DLPFC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are outpatients;
- are voluntary and competent to consent to treatment;
- are ≥ 18 years;
- have a score ≥ 26 on the IDS-30-SR;
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
Key exclusion criteria (10 listed)
- have active suicidal intent;
- are pregnant;
- have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
- have a concomitant major unstable medical illness;
- have any significant form of dementia or any history of epilepsy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationrTMS 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. | Device | Intermittent Theta Burst Stimulation (iTBS), Low Frequency Right (LFR) |
Primary outcome
Depression severity
Time frame: one week post treatment
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.
2 secondary outcomes
Suicidal ideation
Time frame: one week post treatment
Anxiety severity
Time frame: one week post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Episode
RecruitingObservational study
Sensation Seeking and TMS Response in TRD
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RecruitingPhase 1
Remote Medical Monitoring of Patients With Depression
Depression Chronic, Depression and Quality of Life
RecruitingPhase 2
ALTO-100 in Bipolar Disorder With Depression (BD-D)
Bipolar Disorder I or II With a Major Depressive Episode
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Deep Phenotyping for Clinical Inferring Response in Treatment Resistant Depression
Depressive; Disorder, Major, Single Episode, Major, With Psychotic Symptoms, Depressive; Disorder, Major, Single Episode, Major (Without Psychotic Symptoms)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fidel Vila-Rodriguez, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Major Depressive Episode and Major Depressive Disorder, run by University of British Columbia 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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Depression severity (time frame: one week post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.