Left vs. Right Non-Inferiority Trial
LeRNIT
Left Intermittent Theta Burst Stimulation vs. Right Low Frequency Repetitive Transcranial Magnetic Stimulation Effectiveness in Depression and Suicidal Ideation: A Randomized Non-Inferiority Trial
1 other identifier
interventional
420
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Nov 2021
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedNovember 10, 2021
November 1, 2021
4.2 years
August 2, 2021
November 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Depression severity
17 item Hamilton Depression Rating Scale (HDRS-17) Change
30 days
Secondary Outcomes (3)
Suicidal ideation
30 days
Anxiety severity
30 days
Depression severity
30 days
Study Arms (2)
Intermittent Theta Burst Stimulation (iTBS)
ACTIVE COMPARATORiTBS to the L-DLPFC
Low Frequency Right (LFR)
ACTIVE COMPARATOR1Hz stimulation to the R-DLPFC
Interventions
rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.
Intermittent Theta Burst Stimulation (iTBS)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, V6T 2A1, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fidel Vila-Rodriguez, MD, PhD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Study doctors and raters obtaining outcome measures will be blind to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 11, 2021
Study Start
November 8, 2021
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
November 10, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share