Status:
COMPLETED
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
Lead Sponsor:
Cervel Neurotech, Inc.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01909232
Start Date
July 1 2013
End Date
July 1 2014
Last Update
July 28 2016
Active Locations (6)
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1
Emory University
Atlanta, Georgia, United States, 30306
2
Sheppard-Pratt Health System
Baltimore, Maryland, United States, 21285
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227