Randomized Controlled Trial of Conventional vs Theta Burst rTMS
NCT ID: NCT01887782
Last Updated: 2017-01-30
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
NA
414 participants
INTERVENTIONAL
2013-09-30
2016-10-31
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
DOUBLE
Study Groups
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HFL rTMS
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
HFL rTMS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
iTBS
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
iTBS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Interventions
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HFL rTMS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
iTBS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Eligibility Criteria
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Inclusion Criteria
* voluntary and competent to consent
* Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of 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 HAMD-17 item
* 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 Health Network, Toronto
OTHER
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Daniel Blumberger
Medical Head, Temerty Centre for Therapeutic Brain Intervention
Principal Investigators
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Daniel Blumberger, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health
Jonathan Downar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto Western Hospital
Fidel Vila-Rodriguez, MD
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
Toronto Western Hospital
Toronto, Ontario, Canada
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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Kaster TS, Downar J, Vila-Rodriguez F, Baribeau DA, Thorpe KE, Daskalakis ZJ, Blumberger DM. Differential symptom cluster responses to repetitive transcranial magnetic stimulation treatment in depression. EClinicalMedicine. 2022 Dec 2;55:101765. doi: 10.1016/j.eclinm.2022.101765. eCollection 2023 Jan.
Trevizol AP, Downar J, Vila-Rodriguez F, Thorpe KE, Daskalakis ZJ, Blumberger DM. Predictors of remission after repetitive transcranial magnetic stimulation for the treatment of major depressive disorder: An analysis from the randomised non-inferiority THREE-D trial. EClinicalMedicine. 2020 Apr 30;22:100349. doi: 10.1016/j.eclinm.2020.100349. eCollection 2020 May.
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.
Hsu JH, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM. Impact of prior treatment on remission with intermittent theta burst versus high-frequency repetitive transcranial magnetic stimulation in treatment resistant depression. Brain Stimul. 2019 Nov-Dec;12(6):1553-1555. doi: 10.1016/j.brs.2019.07.011. Epub 2019 Jul 17.
Kaster TS, Downar J, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Blumberger DM. Trajectories of Response to Dorsolateral Prefrontal rTMS in Major Depression: A THREE-D Study. Am J Psychiatry. 2019 May 1;176(5):367-375. doi: 10.1176/appi.ajp.2018.18091096. Epub 2019 Feb 15.
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.
Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
Other Identifiers
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179/2012
Identifier Type: -
Identifier Source: org_study_id
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