TY - JOUR
T1 - Vagus Nerve Stimulation
T2 - 2-Year Outcomes for Bipolar Versus Unipolar Treatment-Resistant Depression
AU - Nierenberg, Andrew A.
AU - Alpert, Jonathan E.
AU - Gardner-Schuster, Erica E.
AU - Seay, Sheila
AU - Mischoulon, David
N1 - Funding Information:
Dr. Nierenberg has served as a consultant for AbbottLaboratories, BrainCells, Bristol-Myers Squibb, GHenaissance, GlaxoSmithKline, Innapharma, Janssen Pharmaceutica, Eli Lilly, Novartis, Pfizer, Sepracor, Shire, and Somerset. He has received grant support from Bristol-Myers Squibb, Cederroth, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Janssen Pharmaceutica, Lichtwer Pharma, Eli Lilly, National Alliance for Research on Schizophrenia and Depression, National Institute of Mental Health, Pfizer, Stanley Foundation, Wyeth-Ayerst. He has received honoraria from Bristol-Myers Squibb, Cyberonics, Forest Pharmaceuticals, GlaxoSmithKline, Eli Lilly, and Wyeth-Ayerst. He has no relevant stock ownership to declare. Dr. Alpert has received research support from Abbott Laboratories, Alkermes, Lichtwer Pharma GmbH, Lorex Pharmaceuticals; Aspect Medical Systems, Astra-Zeneca, Bristol-Myers Squibb Company, Cephalon, Cyberonics, Eli Lilly & Company, Forest Pharmaceuticals, GlaxoSmithKline, J&J Pharmaceuticals, Novartis, Organon, PamLab LLC, Pfizer, Pharmavite, Roche, Sanofi/Synthelabo, Solvay Pharmaceuticals, and Wyeth-Ayerst Laboratories. He lists receiving speakers' honoraria from Eli Lilly & Company, Janssen, Organon. He reports advisory/consultative relationships with Eli Lilly & Company, Pamlab LLC, and Pharmavite LLC. Erica E. Gardner-Schuster has no conflict of interest to declare. Sheila Seay, M.A., is an employee and stockholder of Cyberonics. Dr. Mischoulon has received research support from Amarin, Bristol-Myers Squibb Company, Cederroth, Lichtwer Pharma GmbH, Nordic Naturals, and SwissMedica. He is a co-owner of the patent for PMS Escape and has received speaker's honoraria from Bristol-Meyers Squibb Company, Pamlab, and Pfizer. He reports an advisory/consultative relationship with Pamlab.
PY - 2008/9/15
Y1 - 2008/9/15
N2 - Background: The outcome of vagus nerve stimulation (VNS) for patients with bipolar treatment-resistant depression (TRD) has not been well characterized. This study describes the outcome of VNS for bipolar TRD patients participating in the acute and longitudinal pivotal trials and compares their outcome with unipolar TRD patients in the same trials. Methods: Of 235 participants enrolled in the acute study, 25 (11%) were diagnosed with DSM-IV bipolar I or II disorder. A sham-controlled 12-week trial of VNS preceded 2 years of open treatment. Bipolar and unipolar subjects were compared on baseline characteristics as well as acute and long-term outcomes. Results: At baseline, bipolar TRD was as severe as unipolar TRD but with depressive episodes of shorter duration and more failed antidepressant trials/year. Acute, 1-year, and 2-year outcomes were similar for both groups, even when the definition of response for bipolar TRD was expanded to include lack of manic symptoms. Conclusions: Bipolar TRD is a serious condition. In this hypothesis-generating analysis, VNS short- and long-term effects on bipolar and unipolar TRD were similar. Because these analyses were post hoc, these findings should not be interpreted as warranting clinical inference regarding effectiveness of VNS in patients with bipolar depression.
AB - Background: The outcome of vagus nerve stimulation (VNS) for patients with bipolar treatment-resistant depression (TRD) has not been well characterized. This study describes the outcome of VNS for bipolar TRD patients participating in the acute and longitudinal pivotal trials and compares their outcome with unipolar TRD patients in the same trials. Methods: Of 235 participants enrolled in the acute study, 25 (11%) were diagnosed with DSM-IV bipolar I or II disorder. A sham-controlled 12-week trial of VNS preceded 2 years of open treatment. Bipolar and unipolar subjects were compared on baseline characteristics as well as acute and long-term outcomes. Results: At baseline, bipolar TRD was as severe as unipolar TRD but with depressive episodes of shorter duration and more failed antidepressant trials/year. Acute, 1-year, and 2-year outcomes were similar for both groups, even when the definition of response for bipolar TRD was expanded to include lack of manic symptoms. Conclusions: Bipolar TRD is a serious condition. In this hypothesis-generating analysis, VNS short- and long-term effects on bipolar and unipolar TRD were similar. Because these analyses were post hoc, these findings should not be interpreted as warranting clinical inference regarding effectiveness of VNS in patients with bipolar depression.
KW - 2-year outcome
KW - bipolar treatment-resistant depression
KW - vagus nerve stimulation
UR - http://www.scopus.com/inward/record.url?scp=49749086886&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=49749086886&partnerID=8YFLogxK
U2 - 10.1016/j.biopsych.2008.04.036
DO - 10.1016/j.biopsych.2008.04.036
M3 - Article
C2 - 18571625
AN - SCOPUS:49749086886
SN - 0006-3223
VL - 64
SP - 455
EP - 460
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 6
ER -