The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.
This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment ) in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medication. Approximately 146 subjects will be enrolled in the study. The study population consists of subjects with MDD who have failed adequate medication treatment and who are in a current depressive episode. The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private research centers. The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4 weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and assessments during the screening and baseline and throughout treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
Kadima Neuropsychiatry
La Jolla, California, United States
RECRUITINGCalNeuro Research Group
Los Angeles, California, United States
RECRUITINGHDRS-21 Score Change From Baseline
Change from baseline in HDRS-21 scores at week 6 post-randomization in the H7 group compared to the H1 group
Time frame: Week 6 post randomization
Response Rate in HDRS-21
Percentage of patients with reduction in HDRS-21 score from baseline in the H7 group compared to the H1 group
Time frame: Week 6 post randomization
Remission Rate
Percentage of patients in remission, at week 6 post-randomization assessment
Time frame: Week 6 post randomization
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Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, United States
RECRUITINGAdvanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
RECRUITINGMedical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGGreenbrook TMS NeuroHealth Centers
McLean, Virginia, United States
RECRUITINGCenter for Addiction & Mental Health (CAMH)
Toronto, Ontario, Canada
RECRUITINGDr. Hadar Shalev
Beersheba, Israel
RECRUITING