Left vs. Right Non-Inferiority Trial

Launched by UNIVERSITY OF BRITISH COLUMBIA · Aug 7, 2021

Keywords

ClinConnect Summary

The Left vs. Right Non-Inferiority Trial is studying two different treatments for people with treatment-resistant depression, which is when standard antidepressants haven't worked. The goal is to see if a new method called low-frequency repetitive transcranial magnetic stimulation (LFR) is just as effective as an existing method known as intermittent theta-burst stimulation (iTBS). This trial is currently looking for participants who are between the ages of 18 and 65, are outpatients, and have been diagnosed with major depressive disorder. Eligible participants should have tried at least two antidepressants without success or have not responded adequately to their current medication.

If you join this study, you'll receive either LFR or iTBS treatment over a period of time, and you'll have regular appointments to monitor your progress. It's important to note that the trial excludes individuals with certain conditions, such as active suicidal thoughts, severe medical illnesses, or a history of certain mental health disorders. This trial may provide hope for those who haven’t found relief from their depression through other treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. are female or male;
• • 2. are outpatients;
• • 3. are voluntary and competent to consent to treatment;
• • 4. have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0;
• • 5. are 18yo to 65yo;
• • 6. have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of \> 3 in the current episode OR have been unable to tolerate at least two separate trials of antidepressants at less than the minimum adequate dose and/or duration (ATHF 1 or 2);
• • 7. have a score ≥ 18 on the Hamilton Depression Rating Scale (HDRS-17 item);
• • 8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
• • 9. are able to adhere to the treatment schedule;
• • 10. pass the TMS and MRI adult safety screening questionnaires.
• Exclusion Criteria:
• • 1. have a history of substance use within the last 3 months;
• • 2. have a concomitant major unstable medical illness;
• • 3. have active suicidal intent;
• • 4. are pregnant;
• • 5. have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder;
• • 6. have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD;
• • 7. have failed a course of ECT in the current episode;
• • 8. have any significant neurological disorder, any history of seizure (except those therapeutically induced by ECT), significant head trauma with loss of consciousness for \> 5 min;
• • 9. have any intracranial implant (e.g., aneurysm clips) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
• • 10. are participating in psychotherapy, must have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;
• • 11. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
• • 12. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);