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

Cervel Neurotech

Status

Completed

Conditions

Depressive Disorder, Major

Treatments

Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT01909232

CN-CFS-TRMD-2

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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