Neuronetics, Inc., the maker of a non-drug depression treatment, has announced enrollment of the first five patients in an open-label clinical trial to evaluate NeuroStar TMS Therapy® System in women with major depressive disorder (MDD) who experience postpartum symptoms.
Background
Postpartum depression is a treatable mental condition that reportedly occurs in one in seven women after giving birth, generally within the first three months after delivery. The exact causes of the condition are unknown, but factors that may contribute include changes in hormone levels, changes in work and social relationships, having less free time, a lack of sleep and concerns about motherhood.
If left untreated, postpartum depression can last for months or even years, making it a significant healthcare challenge.
NeuroStar TMS treatment stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses. Treatment is administered as a 37-minute outpatient procedure, available by prescription only and performed under the supervision of a healthcare professional. The treatment does not require anesthesia or sedation, and patients remain awake and alert.
Neuronetics says its system is supported by clinical data from 800 patients in six trials for MDD that conclusively proves the safety and efficacy of the world’s leading clinical TMS system. NeuroStar TMS is an established therapy with NeuroStar units available worldwide including more than 500 across the U.S., that have treated more than 13,000 patients.
The system was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD). NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
The study
Sites across the U.S. are enrolling females ages 18-50 who have been diagnosed with MDD with postpartum onset within six months of childbirth. Investigators have established the primary endpoint as safety and efficacy observed following acute treatment with NeuroStar TMS Therapy (up to eight weeks); the secondary endpoint is safety and efficacy observed in the study population in clinical follow up through 12 months.
Physician comments
“Postpartum depression is a significant health issue for new moms and women, particularly those who are breastfeeding, who may hesitate to seek treatment with oral medications, given the potential side effects,” said Howard Weeks, M.D., Principal Investigator and Assistant Professor of Psychiatry at the University of Utah. “The initiation of this new study trial will allow us to evaluate the use of NeuroStar TMS as a possible non-invasive, non-drug treatment option for women who experience postpartum depression.”
Source: Neuronetics, Inc., PR Newswire
published: July 31, 2013 in: Clinical Studies/Trials, Neuro