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

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

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.

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