Comparing two types of brain stimulation for treatment-resistant depression and anxiety

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

This study is testing two types of brain stimulation to see which one helps people with treatment-resistant depression and anxiety feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05028738 on ClinicalTrials.gov

What this trial studies

This trial evaluates the feasibility of a pragmatic approach to compare intermittent theta-burst stimulation (iTBS) and low frequency repetitive transcranial magnetic stimulation (LFR) in patients with treatment-resistant depression (TRD). The study aims to recruit 100 outpatients and assess various depression and anxiety scales while incorporating patient preferences and digital phenotyping for future trials. Key objectives include determining recruitment feasibility, retention rates, and patient engagement in treatment options when initial responses are inadequate.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged 18 and older with treatment-resistant depression who meet specific inclusion criteria.

Not a fit: Patients with active suicidal intent, certain psychiatric disorders, or significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new insights into effective treatment options for patients suffering from treatment-resistant depression and anxiety.

How similar studies have performed: Other studies have shown promise with similar approaches, but this trial aims to establish a novel pragmatic framework for evaluating treatment options.

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).

Where this trial is running

Vancouver, British Columbia

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

Study contacts

• Principal investigator: Fidel Vila-Rodriguez, MD, PhD — University of British Columbia
• Study coordinator: Jessica Layton

Conditions: Major Depressive Episode, Major Depressive Disorder, Pragmatic, Patient-oriented research, TMS, Treatment-resistant depression, Transcranial Magnetic Stimulation, rTMS