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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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2014-03-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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10Hz
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks
10Hz
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
iTBS
intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks
iTBS
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Interventions
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10Hz
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
iTBS
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Eligibility Criteria
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Inclusion Criteria
* voluntary and competent to consent
* Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
* 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 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
* have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
* have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
* Pass the TMS adult safety screening (TASS) questionnaire
* have normal thyroid functioning based on pre-study blood work
Exclusion Criteria
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
* have active suicidal intent
* are pregnant
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
* have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
18 Years
65 Years
ALL
No
Sponsors
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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
Role: PRINCIPAL_INVESTIGATOR
University of British Columia
Locations
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Non-Invasive Neurostimulation Therapies lab, University of British Columbia
Vancouver, British Columbia, Canada
Countries
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References
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Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.
Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.
Related Links
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Laboratory Website
Other Identifiers
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H13-02340
Identifier Type: -
Identifier Source: org_study_id
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