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Left vs. Right Non-Inferiority Trial

RecruitingNAAges 18 Years - 65 YearsAllUniversity of British Columbia
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to test the hypothesis that low-frequency rTMS (LFR) works as well as the established intermittent thetaburst rTMS (iTBS) treatment for treatment resistant depression (TRD).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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);
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What it tests

  • Repetitive Transcranial Magnetic Stimulation
  • Intermittent Theta Burst Stimulation (iTBS)
  • Low Frequency Right (LFR)
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Where

2 sites
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, Canada
Centre for Addiction and Mental Health
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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