High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

Study Overview
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Brief Summary
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This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.

Official Title
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A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder

Conditions
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Depression

Intervention / Treatment
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* Device: High-frequency rTMS
* Device: Low-frequency rTMS
* Device: Sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Patient): Voluntary and competent to consent to treatment MINI confirmed diagnosis of MDD Outpatient Between the ages of 18-65 Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode. Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening Must adhere to study assessment and intervention schedule. Pass the TMS Safety Screening Questionnaire. Exclusion Criteria (Patient): Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical 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 Have received rTMS for any previous indication due to the potential compromise of subject blinding.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-frequency rTMS<br>20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks | Device: High-frequency rTMS<br>* 20 Hz active stimulation, twice daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|
| Experimental: Low-frequency rTMS<br>1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks | Device: Low-frequency rTMS<br>* 1 Hz active stimulation, twice daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|
| Sham Comparator: Sham rTMS<br>Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks | Device: Sham rTMS<br>* Sham stimulation, twice daily<br>* Other names: Magventure Cool DB80 Active/Placebo Coil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D17 score | Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission. | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II |  | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment | 
| Beck anxiety inventory |  | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, brain stimulation