This research study evaluates an experimental device for the treatment of the depressed phase of Bipolar Disorder Type II. Repetitive Transcranial Magnetic Stimulation (rTMS) is an experimental procedure where a device delivers an alternating magnetic field to a focal area of the brain. When the coil is placed against the scalp on the left frontal area of the head, the magnetic field is focused to a region of the brain that is thought to be involved in depression. This study is intended to test if rTMS can affect this region of the brain in a way that improves the symptoms of depression related to Bipolar Disorder Type II. The purpose of this study is to obtain safety and efficacy information regarding the use of rTMS(Repetitive Transcranial Magnetic Stimulation) for patients in the depressed phase of Bipolar Disorder Type II.
This is a double-blind randomized controlled trial of rTMS for outpatients in the depressive phase of BD-II. Participants will be evaluated at UT Southwestern Medical Center at Dallas. Forty eligible subjects will be randomized to either active treatment (n=20) or sham (no stimulation, n=20). Each subject will receive treatment 5 days per week for a total of 6 weeks. At the end of the 6 weeks, those who remain depressed will have the option of receiving 6 additional weeks of open rTMS treatment. We require these participants to meet the same eligibility criteria in the open phase (i.e. MADRS ≥15, YMRS \<12) as in the initial double blind phase. At the completion of treatment, a follow-up appointment will be scheduled with a study physician to ensure that the participant is properly transitioning to clinical care and is not having a significant change in clinical status. Those who do not already have a treating physician will be referred to a new provider.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Repetitive transcranial magnetic stimulation (rTMS).
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
QIDS-C (Quick Inventory of Depressive Symptomatology-Clinical Rated)
Time frame: 3 year
MADRS(Montgomery Asberg Depression Rating Scale)
Time frame: 3 year
IDS-C (Inventory of Depressive Symptomatology- Clinician Rated)
Time frame: 3 year
QIDS-SR (Quick Inventory of Depressive Symptomatology-Self Report)
Time frame: 3 year
YMRS (Young Mania Rating Scale)
Time frame: 3 year
Neuropsychological Testing
Time frame: 3 year
rTMS safety/adverse events
Time frame: 3 year
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