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

Launched by UNIVERSITY OF BRITISH COLUMBIA · Aug 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of brain stimulation treatments to help people who are dealing with severe depression and anxiety that haven’t improved with other therapies. The study involves 100 patients who will receive either intermittent theta-burst stimulation (iTBS) or low-frequency repetitive transcranial magnetic stimulation (LFR). The goal is to see which method is more effective in reducing symptoms of depression and anxiety.

To participate in the trial, individuals must be at least 18 years old and currently receiving outpatient care. They should have a certain level of depression as measured by a specific rating scale, and they must not have made any recent changes to their mental health medications. Importantly, candidates should not have a history of severe mental illnesses like schizophrenia or bipolar disorder, and they should pass a safety questionnaire for the brain stimulation procedure. Participants can expect to follow a treatment schedule and will receive care and monitoring throughout the trial. This study is currently recruiting and is open to all genders.

Gender

ALL

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).