Major Depressive Disorder
Conditions
Brief summary
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response
Interventions
DEVICE10Hz
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
DEVICEiTBS
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score | baseline, 1, 4, and 12 weeks post-treatment | A 50% improvement in the score is considered response to rTMS. A final score of \<8 is categorized as remission. |
Countries
Canada
Outcome results
None listed