Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Study Overview
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Brief Summary
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This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.

Official Title
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Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression

Conditions
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Depressive Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are outpatients are voluntary and competent to consent to treatment are between the ages of 18 and 85, inclusive are able to adhere to the treatment schedule pass the TMS safety-screening questionnaire have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening Exclusion Criteria: previous rTMS treatment 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 have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD have a diagnosis of any psychotic disorder have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study clinically significant laboratory abnormality, in the opinion of the investigator currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview) any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, single-arm, open label feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS<br>Treatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* The treatment will be delivered by trained medical personnel.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe) | Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission. | Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe) | Outcome measured by a change in depression score from baseline (week prior to treatment) to 1 week and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 7 or less is categorized as remission. | Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, TMS, repetitive transcranial magnetic stimulation, major depressive disorder, major depression, MDD