Status:
COMPLETED
Randomized Controlled Trial of Conventional vs Theta Burst rTMS
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT01887782
Start Date
September 1 2013
End Date
October 1 2016
Last Update
January 30 2017
Active Locations (3)
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1
Non-Invasive Neurostimulation Therapies Centre, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1
2
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
3
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4