PMID- 18211128
OWN - NLM
STAT- MEDLINE
DCOM- 20080404
LR  - 20190902
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 69
IP  - 2
DP  - 2008 Feb
TI  - A 1-year pilot study of vagus nerve stimulation in treatment-resistant 
      rapid-cycling bipolar disorder.
PG  - 183-9
AB  - 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 < or = .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.
FAU - Marangell, Lauren B
AU  - Marangell LB
AD  - Mood Disorders Center, Menninger Department of Psychiatry, Baylor College of 
      Medicine, and Department of Veterans Affairs, Houston, Texas, USA. 
      drlauren@lilly.com
FAU - Suppes, Trisha
AU  - Suppes T
FAU - Zboyan, Holly A
AU  - Zboyan HA
FAU - Prashad, Sandhya J
AU  - Prashad SJ
FAU - Fischer, Grace
AU  - Fischer G
FAU - Snow, Diane
AU  - Snow D
FAU - Sureddi, Suresh
AU  - Sureddi S
FAU - Allen, John C
AU  - Allen JC
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antimanic Agents)
SB  - IM
MH  - Adult
MH  - Age of Onset
MH  - Antimanic Agents/therapeutic use
MH  - Bipolar Disorder/drug therapy/*therapy
MH  - Electric Stimulation Therapy/adverse effects/*methods
MH  - Female
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Psychiatric Status Rating Scales
MH  - Time Factors
MH  - Treatment Outcome
MH  - *Vagus Nerve
EDAT- 2008/01/24 09:00
MHDA- 2008/04/05 09:00
CRDT- 2008/01/24 09:00
PHST- 2008/01/24 09:00 [pubmed]
PHST- 2008/04/05 09:00 [medline]
PHST- 2008/01/24 09:00 [entrez]
AID - ej07m03183 [pii]
AID - 10.4088/jcp.v69n0203 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2008 Feb;69(2):183-9. doi: 10.4088/jcp.v69n0203.