A one-year comparison of vagus nerve stimulation with treatment as usual for treatment-resistant depression.
BACKGROUND
Previous reports have described the effects of vagus nerve stimulation plus treatment as usual (VNS+TAU) during open trials of patients with treatment-resistant depression (TRD). To better understand these effects on long-term outcome, we compared 12-month VNS+TAU outcomes with those of a comparable TRD group.


METHODS
Admission criteria were similar for those receiving VNS+TAU (n = 205) or only TAU (n = 124). In the primary analysis, repeated-measures linear regression was used to compare the VNS+TAU group (monthly data) with the TAU group (quarterly data) according to scores of the 30-item Inventory of Depressive Symptomatology-Self-Report (IDS-SR(30)).


RESULTS
The two groups had similar baseline demographic data, psychiatric and treatment histories, and degrees of treatment resistance, except that more TAU participants had at least 10 prior major depressive episodes, and the VNS+TAU group had more electroconvulsive therapy before study entry. Vagus nerve stimulation plus treatment as usual was associated with greater improvement per month in IDS-SR(30) than TAU across 12 months (p < .001). Response rates according to the 24-item Hamilton Rating Scale for Depression (last observation carried forward) at 12 months were 27% for VNS+TAU and 13% for TAU (p < .011). Both groups received similar TAU (drugs and electroconvulsive therapy) during follow-up.


CONCLUSIONS
This comparison of two similar but nonrandomized TRD groups showed that VNS+TAU was associated with a greater antidepressant benefit over 12 months.
George
Mark S
MS
Department of Psychiatry, Medical University of South Carolina, 67 President Street #502-N, Charleston, SC 29425, USA. georgem@musc.edu
Rush
A John
AJ
Marangell
Lauren B
LB
Sackeim
Harold A
HA
Brannan
Stephen K
SK
Davis
Sonia M
SM
Howland
Robert
R
Kling
Mitchel A
MA
Moreno
Francisco
F
Rittberg
Barry
B
Dunner
David
D
Schwartz
Thomas
T
Carpenter
Linda
L
Burke
Michael
M
Ninan
Philip
P
Goodnick
Paul
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003866:Depressive Disorder / Q000628:therapy*; D004351:Drug Resistance; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D013997:Time Factors; D016896:Treatment Outcome; D014630:Vagus Nerve / Q000502:physiology / Q000528:radiation effects*
D000928:Antidepressive Agents