New Pilot Study Finds the Fisher Wallace Stimulator® Effective in Treating Bipolar Depression
FDA-Cleared Wearable Device Available to Treat Six Million Bipolar Depression Patients
A pilot study conducted at Mount Sinai Beth Israel and published in the Journal of Nervous and Mental Disease shows that Bipolar II Depression (BD II) patients who received daily treatment with the Fisher Wallace Stimulator® experienced significant reduction in self-reported depression symptoms compared to patients using a placebo device. No side effects or adverse events were experienced by patients in the study.
The double-blind, placebo-controlled study investigated the safety and effectiveness of the Fisher Wallace Stimulator®, the leading brand of neurostimulation device, for the treatment of Bipolar II Depression (BD II). After randomization, the active group received 2 mA of neurostimulation for 20 minutes on a daily basis, five days a week for two weeks, whereas the placebo group had the placebo device turned on and off. Symptom nonremitters from both groups received an additional 2 weeks of open-label active treatment. Active treatment but not placebo treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week maintaining significance until week 4.
Chip Fisher, President of Fisher Wallace Laboratories, said: "We are very grateful to the world-class team at Mount Sinai, led by Dr. Igor Galynker, that performed this research and statistical analysis with a level of integrity that is unimpeachable. The emergence of our device as a low-risk treatment option for bipolar depression will profoundly improve outcomes for millions of patients."
Designed to be used at home for 20 minutes on a daily basis, the device works by gently stimulating the brain to produce serotonin and other neurotransmitters that improve mood and sleep, and there is evidence that it improves the brain's ability to regulate the limbic system. The Fisher Wallace Stimulator® has been proven to be safe and effective in multiple published studies and causes no serious side effects.
Kelly Roman, CMO of Fisher Wallace Laboratories, said: "Today is a milestone in the evolution of wearable technology. Patients who suffer from bipolar depression can start using this device today, and psychiatrists can feel confident about it from a risk benefit perspective."
Fisher Wallace Laboratories manufactures and markets the Fisher Wallace Stimulator®, a patented neurostimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia. The Fisher Wallace Stimulator® is also approved by Health Canada for over-the-counter treatment of insomnia and chronic pain, and by the European Union for over-the-counter treatment of depression, anxiety and insomnia. To purchase a device, patients may visit www.fisherwallace.com.
The Richard and Cynthia Zirinsky Center for Bipolar Disorder at Mount Sinai Beth Israel, formerly the Family Center for Bipolar Disorder, is one of the nation’s leading research institutions and clinics that focuses on the treatment of bipolar disorder. Director Igor Galynker, MD, PhD, is also Professor of Psychiatry and Associate Chairman for Research, Icahn School of Medicine.