Pilot Study Comparing 10hz vs Theta Burst Stimulation

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

Official Title
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Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: 10Hz
* 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 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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10Hz<br>High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks | Device: 10Hz<br>* Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System<br>|
| Active Comparator: iTBS<br>intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks | Device: iTBS<br>* Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score | A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission. | baseline, 1, 4, and 12 weeks post-treatment |