Left vs. Right Non-Inferiority Trial

  • STATUS
    Recruiting
  • End date
    Feb 1, 2026
  • participants needed
    420
  • sponsor
    University of British Columbia
Updated on 18 November 2021
antidepressants
depressed mood
transcranial magnetic stimulation
hdrs

Summary

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).

Description

In this multi-centre, triple-blinded, non-inferiority trial 420 patients with TRD will be recruited at two academic centres (UBC, CAMH). Patients will be randomised to receive either iTBS or LFR for 30 sessions. The primary outcome will be the improvement on a depression scale. Secondary outcome will be improvement of suicidal ideation. A secondary aim is to test the predictive capacity of a novel, easy to implement heart rate based biomarkers (i.e. heart rate variability).

Details
Condition Endogenous depression, Major depression, Depression (Adult and Geriatric), Depression (Major/Severe), Major Depressive Episode, Depression (Treatment-Resistant), major depressive disorder, single episode, Depression (Adolescent), major depressive disorders, Depression, Depressed, major depressive disorder, depressed mood, miserable, Depression (Pediatric), depressive disorder, depressive disorders
Treatment Repetitive transcranial magnetic stimulation, intermittent theta burst stimulation (iTBS), Low Frequency Right (LFR)
Clinical Study IdentifierNCT04999553
SponsorUniversity of British Columbia
Last Modified on18 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

are female or male
are outpatients
are voluntary and competent to consent to treatment
have a DSM 5 diagnosis of MDD,55 single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 7.0
are 18yo to 65yo
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)
have a score 18 on the Hamilton Depression Rating Scale (HDRS-17 item)
have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
are able to adhere to the treatment schedule
pass the TMS and MRI adult safety screening questionnaires

Exclusion Criteria

have a history of substance use within the last 3 months
have a concomitant major unstable medical illness
have active suicidal intent
are pregnant
have a lifetime (MINI) diagnosis of any psychotic or bipolar disorder
have a MINI anxiety disorder or personality disorder assessed by a study investigator to be primary and causing greater impairment than MDD
have failed a course of ECT in the current episode
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
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
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
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)
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