Randomized Controlled Trial of Conventional vs Theta Burst rTMS
This trial has been completed.
|Condition||major depressive disorder|
|Treatments||hfl rtms, itbs|
|Sponsor||Centre for Addiction and Mental Health|
|Collaborator||University Health Network, Toronto|
|Start date||September 2013|
|End date||July 2016|
|Trial size||414 participants|
|Trial identifier||NCT01887782, 179/2012|
This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the two treatment protocols have similar effectiveness in treating major depression.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Vancouver, Canada||Non-Invasive Neurostimulation Therapies Centre, University of British Columbia||completed|
|Toronto, Canada||Toronto Western Hospital||completed|
|Toronto, Canada||Centre for Addiction and Mental Health||completed|
|Intervention model||parallel assignment|
|Masking||participant, outcomes assessor|
time frame: baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment
All participants from 18 years up to 65 years old.
Inclusion Criteria: - outpatients - 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 history of substance dependence or abuse within the last 3 months - 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
|Official title||A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder|
|Principal investigator||Daniel Blumberger, MD, MSc|
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