Neuronetics Announces Launch of First Ever Randomized, Controlled Clinical Trial to Evaluate Non-Drug NeuroStar TMS Therapy® in Adolescent Patients with Major Depressive Disorder. This study will Examine Acute and Long-Term Benefits of NeuroStar TMS, Including Symptom Reduction and Remission Rates.
[Press Release: MALVERN, Pa., Nov. 2, 2015]
Neuronetics, Inc., the market leader in Transcranial Magnetic Stimulation (TMS) technology, announced today the start of enrollment for a randomized controlled clinical trial to evaluate the acute and long-term effectiveness of NeuroStar TMS Therapy® in adolescent patients 12-21 years of age living with major depressive disorder (MDD). This is the first randomized, controlled clinical trial to investigate treatment with TMS in adolescent patients with treatment resistant depression. Approximately 11 percent of adolescents living in the U.S. have been diagnosed with a depressive disorder1 .
Although the disease state is a continuum into adulthood, symptoms in adolescents can differ from those seen in adult patients. Recognizable symptoms include:
- Complaints of feeling sick
- Refusal to participate in daily activities like going to school
- Misbehavior in the classroom
- Excessive worry of losing a caregiver.2
According to Christopher Thatcher, President and CEO of Neuronetics.“The physical and emotional strain of major depressive disorder can be debilitating for the youth living with it and for their families,” Thatcher goes on to say that, "We are thankful that funding from a Series F Financing Round earlier this year, from GE Ventures and our other investors, will enable us to conduct this important clinical trial, which will further our understanding of the potential role of NeuroStar TMS Therapy in treating depression in adolescents.”
The trial will evaluate the safety and efficacy of NeuroStar TMS in approximately 100 adolescent patients in study sites across the U.S and Canada, using a six-week acute treatment course with followup after six-months. Patients who do not improve have the option to enter the open-label phase and receive known active TMS treatment. All who improve will then continue in the follow-up phase for 6 months, with TMS retreatment as necessary.
Dr. John Campo, Chair of the Department of Psychiatry and Behavioral Health at The Ohio State University College of Medicine and Wexner Medical Center said, “It is our hope that NeuroStar TMS Therapy will prove to be an effective treatment for managing the troubling symptoms and impairment associated with adolescent Major Depressive Disorder (MDD), which affects approximately 2.6 million young people in the United States. TMS is an appealing nonpharmacologic option with a promising tolerability profile that we hope to confirm in this study,” He also said “Patients or their parents and caregivers should speak with a healthcare provider if they are interested in learning more about how to participate in this clinical trial.”
For more information about Transcranial Magnetic Stimulation, TMS Therapy, and where to get help for depression, call us at TMS Solutions at 1-970-697-1020. To learn more about TMS Therapy and clinical trials, or search for other TMS studies, please visit www.tmssolutions.com .
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For more information about the trial and enrollment, see ClinicalTrials.gov, identifier: NCT02586688. 1 J Am Acad Child Adolesc Psychiatry. 2010 October ; 49(10): 980–989. doi:10.1016/j.jaac.2010.05.017. 2 National Institute of Mental Health. (2014). Depression in Children and Adolescents Fact Sheet.