Neurocardiac Predictors of Treatment Response to RTMS in Depression
NCT ID: NCT05139862
Last Updated: 2024-12-24
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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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2025-05-01
2028-12-01
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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active iTBS
Active intermittent theta-burst stimulation (iTBS) rTMS session on the left dorsolateral prefrontal cortex (L-DLPFC)
Repetitive Transcranial Magnetic Stimulation
This study utilizes intermittent theta burst stimulation (iTBS) to the left DLPFC.
Interventions
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Repetitive Transcranial Magnetic Stimulation
This study utilizes intermittent theta burst stimulation (iTBS) to the left DLPFC.
Other Intervention Names
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Eligibility Criteria
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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, single or recurrent confirmed by Mini-International Neuropsychiatric Interview (MINI) version 6.0;
5. are between the ages of 18 and 65 years;
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. 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. 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 ever failed a course of ECT;
8. have previously received rTMS;
9. 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;
10. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
11. if 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;
12. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
13. are currently taking lorazepam greater than 2 mg daily (or equivalent) or any dose of an anticonvulsant, due to the potential to limit rTMS efficacy;
14. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview);
15. have failed more than three adequate trials (ATHF \> 3) of medication in the current episode.
19 Years
65 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Responsible Party
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Fidel Vila-Rodriguez, MD, PhD, FRCPC, DFAPA
Principle Investigator
Principal Investigators
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Fidel Vila-Rodriguez, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, UBC
Locations
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Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Quincy Beck, B.Sc.
Role: primary
Fidel Vila-Rodriguez, M.D., Ph.D.
Role: backup
Other Identifiers
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H19-00648
Identifier Type: -
Identifier Source: org_study_id