A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.

Official Title
-----------------
A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
* Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current major depressive disorder (MDD) Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study Weight less than 350 pounds Exclusion Criteria: Current major depressive disorder episode of more than three years Seizure disorder History of brain injury, stroke or active central nervous system disease Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe Active suicidal intent or plan Other significant psychiatric disorder Alcohol or substance dependence or abuse Prior treatment with transcranial magnetic stimulation Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation If female, pregnant or lactating or planning to become pregnant within the next three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS treatment<br>Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator | Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator<br>* The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.<br>|
| Sham Comparator: Sham rTMS treatment<br>Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator | Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator<br>* The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity | Measured by the 24-item Hamilton Rating Scale for Depression | Baseline to four weeks (the conclusion of rTMS treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity | Measured by the 24-item Hamilton Rating Scale for Depression | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | 
| Clinically significant response | Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score | Baseline to four weeks (the conclusion of rTMS treatment) | 
| Clinically significant response | Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | 
| Remission from depression | Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10 | Baseline to four weeks (the conclusion of rTMS treatment) | 
| Remission from depression | Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10 | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | 
| Change in quality of life | Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form | Baseline to four weeks (the conclusion of rTMS treatment) | 
| Change in quality of life | Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | 
| Incidence of treatment-emergent adverse events and serious adverse events |  | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD, TIMD, Transcranial Magnetic Stimulation, TMS