The purpose of this study is to evaluate the safety and effectiveness of acute NeuroStar TMS therapy in women who have postpartum depression.
Evaluate the antidepressant effectiveness of acute treatment with NeuroStar TMS Therapy in patients with MDD with postpartum onset. Determine the safety of NeuroStar TMS Therapy by assessment of any medically significant, device-related adverse events during acute treatment. Determine the Safety of NeuroStar TMS Therapy by assessment of maternal and infant interactions on standardized bonding questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks. 3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician.
Hartford Hospital Institute of Living
Hartford, Connecticut, United States
UF Health Adult Psychiatry - Springhill
Gainesville, Florida, United States
Harmonex Neuroscience and Research of Pensacola
Pensacola, Florida, United States
Rush University Medical Center
Mean Change in EPDS Score From Baseline to End of Acute (EOA) Treatment
The EPDS is a ten-item questionnaire used for screening for postpartum depression. Total scores range from 0 to 30. Mothers who score above 10 are likely to suffer a depressive illness, while scores above 13 are likely to represent major depression. Higher score at EOA means worse outcome. Once patient reached remission (EPDS\<9), this was EOA treatment and scores were collected.
Time frame: Pre to post treatment (Duration range 4 to 8 weeks)
Percentage of Patients Who Reached Remission After TMS Treatment
An EPDS score less that 10 was used to indicate "remission". The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for ³perinatal´ depression. The EPDS is easy to administer and has proven to be an effective screening tool. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. Women are asked to answer each question in terms of the past seven days.
Time frame: upto 8 weeks plus 3 week taper.
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Chicago, Illinois, United States
Integrative Psychiatry
Louisville, Kentucky, United States
TMS Medical Associates of NY
New York, New York, United States
TMS Center of Lehigh Valley
Allentown, Pennsylvania, United States
University of Utah - Neuropsychiatric Institute
Salt Lake City, Utah, United States