NCT05028738 Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety
| NCT ID | NCT05028738 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Major Depressive Episode |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-10-11 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-10-11 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. are outpatients; 2. are voluntary and competent to consent to treatment; 3. are ≥ 18 years; 4. have a score ≥ 26 on the IDS-30-SR; 5. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening; 6. able to adhere to the treatment schedule; 7. pass the TMS adult safety screening (TASS) questionnaire Exclusion Criteria: 1. have active suicidal intent; 2. are pregnant; 3. have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months; 4. have a concomitant major unstable medical illness; 5. have any significant form of dementia or any history of epilepsy; 6. 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; 7. 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; 8. 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; 9. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators; 10. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Contact & Investigator
Fidel Vila-Rodriguez, MD, PhD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05028738 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Major Depressive Episode. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05028738 currently recruiting?
Yes, NCT05028738 is actively recruiting participants. Contact the research team at ninet.lab@ubc.ca for enrollment information.
Where is the NCT05028738 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05028738 clinical trial?
NCT05028738 is sponsored by University of British Columbia. The principal investigator is Fidel Vila-Rodriguez, MD, PhD at University of British Columbia. The trial plans to enroll 100 participants.