Major Depressive Disorder
Conditions
Keywords
depression, magnetic, brain stimulation, treatment-resistant
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 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.
Interventions
DEVICEiTBS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
DEVICEHFL rTMS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
Sponsors
University Health Network, Toronto
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAM-D17 score | baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment | Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. 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