Neuronetics, Inc., Announces First Patients Enrolled in Clinical Trial to Evaluate NeuroStar TMS Therapy in Women with Postpartum Depression
Open-label Study will Assess the Safety and Efficacy of NeuroStar Transcranial Magnetic Stimulation (TMS) among Postpartum Patients through One Year
Last modified: 2013-07-30T12:45:37Z
Published: Tuesday, Jul. 30, 2013 - 5:44 am
MALVERN, Pa., July 30, 2013 -- /PRNewswire/ -- Neuronetics, Inc., the maker of a non-drug depression treatment, announced today the 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. Postpartum depression affects one in seven new mothers1 and is the most common complication of child birth.2
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. Patients interested in inquiring about the study can get more information by visiting clinicaltrials.gov or by calling Neuronetics' Customer Service Department at 1-877-600-7555.
"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."
For patients with MDD, treatment with NeuroStar TMS 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. Only NeuroStar TMS 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. To learn more about NeuroStar TMS Therapy, please visit www.NeuroStar.com.
About Postpartum Depression Postpartum depression is a treatable mental condition that occurs in 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.3 Symptoms of postpartum depression can include sad feelings, frequent crying, anxiety, irritability, sleep issues, trouble making decisions, the loss of interest to care for oneself, and showing too much (or not enough) concern for the baby.4 If left untreated, postpartum depression can last for months or even years.3
About NeuroStar TMS Therapy® Neuronetics' NeuroStar TMS Therapy 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. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses. The treatment is available by prescription and typically administered daily for 4-6 weeks. For full safety and prescribing information, visit www.NeuroStar.com.
About Neuronetics, Inc. Neuronetics, Inc., is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses. Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation. For more information, please visit www.Neuronetics.com.
NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of Neuronetics, Inc.
References 1 Wisner KL, Sit D, McShea MC, et al. Onset Timing, Thoughts of Self-harm, and Diagnoses in Postpartum Women With Screen-Positive Depression Findings. JAMA Psychiatry. 2013:70(5);490-498. Available at: http://archpsyc.jamanetwork.com/article.aspx?articleid=1666651. Accessed on (July 15, 2013).
2 Zauderer C. Postpartum Depression: How Childbirth Educators Can Help Break the Silence. J Perinat Edu. 2009:18(2);23-31. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684038/. Accessed on (July 15, 2013).
3 U.S. National Library of Medicine. Postpartum depression. Available at: http://www.nlm.nih.gov/medlineplus/ency/article/007215.htm. Accessed on (July 15, 2013).
4 Mayoclinic.com. Postpartum depression: Symptoms. Available at: http://www.mayoclinic.com/health/postpartum-depression/DS00546/DSECTION=symptoms. Accessed on July 17, 2013.
SOURCE Neuronetics, Inc.