Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2021-11-08
2026-02-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intermittent Theta Burst Stimulation (iTBS)
iTBS to the L-DLPFC
Repetitive Transcranial Magnetic Stimulation
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)
Intermittent Theta Burst Stimulation (iTBS)
Low Frequency Right (LFR)
1Hz stimulation to the R-DLPFC
Repetitive Transcranial Magnetic Stimulation
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.
Low Frequency Right (LFR)
Low Frequency Right (LFR)
Interventions
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Repetitive Transcranial Magnetic Stimulation
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)
Intermittent Theta Burst Stimulation (iTBS)
Low Frequency Right (LFR)
Low Frequency Right (LFR)
Eligibility Criteria
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Inclusion Criteria
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
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);
18 Years
65 Years
ALL
No
Sponsors
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Centre for Addiction and Mental Health
OTHER
University of British Columbia
OTHER
Responsible Party
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Fidel Vila-Rodriguez
Principle Investigator
Principal Investigators
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Fidel Vila-Rodriguez, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Afifa Humaira, BSc
Role: primary
Stacey Shim, MSc
Role: primary
Other Identifiers
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H18-00583
Identifier Type: -
Identifier Source: org_study_id