Q. I have a question about the vagal nerve stimulator for bipolar depression. I was wondering if it has FDA approval yet and if not where I could go to get this even if not in this country? I am really desperate to feel better.

I have been on a roller coaster of moods since I was 18 and I am now 27. I can't keep a job or go to school. I have been on just about every drug for depression and bipolar disorder and they don't work. I've also had ECT which was a disappointment. My doctor (as usual) is blaming this on me. All I want is to feel like myself again and I will do anything to feel this way again. Could you tell me where they are doing this procedure?

A. To my knowledge, Vagus Nerve Stimulation (VNS) has not yet been approved by the FDA for treatment of depression or bipolar disorder; however, it is FDA-approved for treatment of refractory partial onset seizures, and it is certainly being used by a few clinician-researchers for the treatment of resistant depression, including bipolar depression.

Recently, Dr. Mustafa Husain (email: mustafahusain@utsouthwestern.edu) and colleagues presented a paper on the use of VNS in 60 patients with treatment-resistant major depression. Eleven of the subjects had bipolar II disorder, depressed phase. About a third of the patients showed a substantial reduction in their depression scores by the end of the study, and there were no major adverse events. For more about this research, you can log on to http://www.nimh.nih.gov/ncdeu/abstracts2001/ncdeu3013.cfm. This site also gives contact information for the other authors, who are in widely-distributed centers throughout the U.S. (e.g., New York State Psychiatric Inst., Medical University of South Carolina, Baylor College of Medicine in Houston).

All that said, I think it is also important to make sure that you have had a very thorough trial of more standard treatments for bipolar disorder, including newer agents such as lamotrigine, oxcarbazepine, and perhaps pramipexole. (Caution: None of these treatments has FDA-approved labeling in bipolar disorder at this time, though my guess is that lamotrigine will get this within the next year. But clinical science is usually several years ahead of the FDA!).

There is also interest in the use of omega-3-fatty acids in bipolar disorder, though the data supporting this approach are quite limited. I'm actually concerned, though, about your statement, "As usual, my doctor is blaming this on me." If that's so, you have a serious problem with the patient-doctor relationship that needs to be addressed. Patients should not be blamed for not getting better! If that's happening, and you can't fix this by discussing it openly and honestly with your doctor, I would strongly recommend seeking a second opinion on your care. This would involve a complete and fresh look at both your diagnosis and treatment.

Perhaps some factor has been overlooked that would explain your poor response to treatment thus far. (For example, has your thyroid function been checked? Are there things going on in your social or emotional life that have not been adequately addressed?). In any case--even if you continue with your current doctor--you may want to consult with an expert in the treatment of bipolar disorder to make sure that you truly have received the proper care and treatment. You may also want to join the National Depressive and Manic-Depressive Association (NDMDA; 800-826-3632) for advice, support, and referral sources.

Good luck--and keep in mind that most people with mood disorders can be helped, given sufficient time and appropriate therapy. Don't give up!

Other Resources:

• More Questions on Bipolar Disorder
• More Questions on Depression

June 2003

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