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A 1-Year Pilot Study of Vagus Nerve Stimulation in Treatment-Resistant Rapid-Cycling Bipolar Disorder

Lauren B. Marangell, M.D.; Trisha Suppes, M.D., Ph.D.; Holly A. Zboyan, M.A.; Sandhya J. Prashad, M.D.; Grace Fischer, B.S.; Diane Snow, Ph.D.; Suresh Sureddi, M.D.; and John C. Allen, Jr., Ph.D.

Objective: Vagus nerve stimulation (VNS) appears to be an effective treatment option for patients with treatment-resistant unipolar and bipolar depression. The aim of the present study was to investigate the efficacy of VNS in a group of patients with treatment-resistant rapid-cycling bipolar disorder (RCBD) who were excluded from previous trials.

Method: Nine outpatients with a DSM-IV-TR diagnosis of treatment-resistant RCBD were treated for 40 weeks with open-label VNS. The first patient was enrolled in June 2001, and the last patient completed the study in July 2005. Patients recorded their depression and mania mood symptoms on a daily basis throughout the study using the National Institute of Mental Health prospective life charting methodology and daily mood ratings. Patients were assessed every 2 weeks during the 2-month baseline period before device activation, every 2 weeks for the remaining 40 weeks of the study, and at the end of the study with the 24-item Hamilton Rating Scale for Depression (HAM-D-24), the 10-item Montgomery-Asberg Depression Rating Scale (MADRS), the Young Mania Rating Scale (YMRS), the Clinical Global Impressions (CGI) scale, the Global Assessment of Functioning (GAF) scale, and the 30-item Inventory of Depressive Symptomatology Self-Report (IDS-SR-30). Any adverse events or device complications were also recorded at each visit. The prospective life charts were analyzed by calculating the area under the curve. Statistical analysis was performed with a mixed-model repeated-measures regression analysis for repeated measures of the various rating scales. Significant p values were <= .05.

Results: Over the 12-month study period, VNS was associated with a 38.1% mean improvement in overall illness as compared to baseline (p = .012), as well as significant reductions in symptoms as measured by the HAM-D-24 (p = .043), MADRS (p = .003), CGI (p = .013), and GAF (p < .001) rating scales. Common adverse events were voice alteration during stimulation and hoarseness.

Conclusion: These data suggest that VNS may be an efficacious and well-tolerated treatment option for patients with treatment-resistant RCBD. Currently, no comparison is available in the literature. Larger randomized trials are needed to verify these findings.

(J Clin Psychiatry January 16, 2008: e1-e7; pii: ej07m03183)

Received March 2, 2007; accepted May 8, 2007. From the Mood Disorders Center, Menninger Department of Psychiatry, Baylor College of Medicine, and the Department of Veterans Affairs, Houston (Drs. Marangell and Prashad and Ms. Zboyan); the Department of Psychiatry, University of Texas Southwestern Medical Center at Dallas, (Drs. Suppes, Snow, and Sureddi and Ms. Fischer); and Cyberonics, Inc., Houston (Dr. Allen), Texas.

This study was supported by a grant from The Stanley Medical Research Institute, Chevy Chase, Md. Cyberonics, Inc., Houston, Tex., provided the devices for the study and assisted with data entry and analyses.

Previously presented at the 44th annual meeting of the American College of Neuropsychopharmacology, December 11-15, 2005, Waikoloa, Hawaii.

The authors thank James M. Martinez, M.D., who assisted with data collection while employed at Baylor College of Medicine. Dr. Martinez has been a consultant for and has received research/grant support and honoraria from Cyberonics, Inc.

Financial disclosure is listed at the end of the article.

Corresponding author and reprints: Lauren B. Marangell, M.D., Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285 (e-mail: drlauren@lilly.com).

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