Major Depressive Disorder Clinical Trial
Official title:
Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Major depressive disorder (MDD) - Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode. - Will not become pregnant during study. Exclusion Criteria: - Seizure disorder. - History of brain injury or active CNS disease. - Metal implants on or in brain, spinal cord, ear, eye or heart. - Current use of proconvulsant medications (e.g., bupropion). - Other significant psychiatric disorder. - Substance use disorder (not including caffeine or nicotine). - 7 or more failed treatment attempts for depression in one's lifetime. - Have failed to clinically remit to an adequate trial of ECT or TMS. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Monash Alfred Psychiatry Research Centre | Melbourne | Victoria |
United States | Emory University | Atlanta | Georgia |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Rush Medical College | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Cervel Neurotech, Inc. |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission from depression | Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post | baseline through 4 weeks post | No |
Secondary | Safety and tolerability of rTMS | Determined by presence and absence of adverse events recorded daily | baseline through 4 weeks post | Yes |
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