The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications.
This is a multi center, randomized, double blind study to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications. The study is designed for a period of 8 weeks of which up to 3 weeks subjects will be tapered down from their medications and treated for 5 weeks. Two follow up visits will be performed at week 6 and 8 after the last TMS treatment. Mood and mental status will be closely monitored with standard psychological scales and assessments
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
24 TMS treatments over 6 weeks .
24 TMS treatments over 6 weeks
Advanced Mental Health Care Inc. - Juno Beach
Juno Beach, Florida, United States
Advanced Mental Health Care Inc. - Palm Beach
Palm Beach, Florida, United States
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
HDRS-21 Score measured by change from baseline.
Time frame: 6 weeks from baseline
Clinical antidepressant remission rate at the 6-week visit
Time frame: 6 weeks from baseline
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Johns Hopkins University
Baltimore, Maryland, United States
Premier Psychiatric Group
Lincoln, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
Medical Uni. Of South Carolina (MUSC)
Charleston, South Carolina, United States
Senior Adults Specialty Research
Austin, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
...and 3 more locations