Randomized Controlled Trial of Conventional vs Theta Burst rTMS

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: HFL rTMS
* Device: iTBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFL rTMS<br>High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks | Device: HFL rTMS<br>* Magventure Cool B70 Coil with either RX100 or RX30 Stimulator<br>|
| Active Comparator: iTBS<br>intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks | Device: iTBS<br>* Magventure Cool B70 Coil with either RX100 or RX30 Stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D17 score | 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. | baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, magnetic, brain stimulation, treatment-resistant