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

Not Applicable

Completed

Interventions: Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Sham rTMS treatment	Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator	Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
Active rTMS treatment	Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator	Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator

Primary Outcome Measures

Name	Time	Method
Change in depression severity	Baseline to four weeks (the conclusion of rTMS treatment)	Measured by the 24-item Hamilton Rating Scale for Depression

Secondary Outcome Measures

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

Locations (6): Sheppard-Pratt Health System
🇺🇸
Baltimore, Maryland, United States
Butler Hospital
🇺🇸
Providence, Rhode Island, United States
CRI Lifetree
🇺🇸
Salt Lake City, Utah, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Dartmouth-Hitchcock Medical Center
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Lebanon, New Hampshire, United States
Kaiser Permanente Center for Health Research
🇺🇸
Portland, Oregon, United States