Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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;
• 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).

Where this trial is running

• Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry, Vancouver, British Columbia, Canada

Who to contact

Jessica Layton · 604-822-7308 · ninet.lab@ubc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05028738.