Depressive Disorder, Major Clinical Trial
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
Verified date | July 2016 |
Source | Cervel Neurotech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | July 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
United States | Sheppard-Pratt Health System | Baltimore | Maryland |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Kaiser Permanente Center for Health Research | Portland | Oregon |
United States | Butler Hospital | Providence | Rhode Island |
United States | CRI Lifetree | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Cervel Neurotech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in depression severity | Measured by the 24-item Hamilton Rating Scale for Depression | Baseline to four weeks (the conclusion of rTMS treatment) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | 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) | No |
Secondary | Incidence of treatment-emergent adverse events and serious adverse events | Baseline to eight weeks (four weeks after the conclusion of rTMS treatment) | Yes |
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