VNS Therapy is approved by the FDA as an add-on, long-term treatment of chronic or recurrent depression for people 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. VNS Therapy is appropriate for people with bipolar treatment-resistant depression who may benefit from a long-term treatment shown to improve over time and last long term.
Of the 205 people evaluated in a major clinical study of VNS Therapy, approximately 10% had been diagnosed with bipolar treatment-resistant depression. About 1 in 3 of these people experienced significant mood improvement with VNS Therapy, the same as for people who had unipolar treatment resistant-depression. The safety and effectiveness of VNS Therapy for this group of people was comparable to people with unipolar treatment-resistant depression. People with bipolar depression were just as likely to experience improvement with VNS Therapy as those with unipolar treatment-resistant depression.1
VNS Therapy is not approved for rapid-cycling bipolar disorder. Research is ongoing to determine the safety and efficacy of VNS Therapy for rapid-cycling bipolar disorder.