Clinical trial NCT02800226: Pilot Study Comparing 10hz vs Theta Burst Stimulation
Official title: Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response


Eligibility criteria: Inclusion Criteria:

* outpatients
* 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 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

Primary outcomes:
measure: Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
timeFrame: baseline, 1, 4, and 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Non-Invasive Neurostimulation Therapies lab, University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columia
name: Fidel Vila-Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.