Vagus nerve stimulation for treatment-resistant depression: A randomized, controlled acute phase trial

被引:407
作者
Rush, AJ
Marangell, LB
Sackeim, HA
George, MS
Brannan, SK
Davis, SM
Howland, R
Kling, MA
Rittberg, BR
Burke, WJ
Rapaport, MH
Zajecka, J
Nierenberg, AA
Husain, MM
Ginsberg, D
Cooke, RG
机构
[1] Univ Texas, SW Med Ctr, Dept Psychiat, Dallas, TX 75390 USA
[2] Baylor Coll Med, S Cent Mental Illness Res Educ & Clin Ctr, Houston, TX USA
[3] Cyberon Inc, Houston, TX USA
[4] New York State Psychiat Inst & Hosp, Dept Biol Psychiat, New York, NY 10032 USA
[5] Columbia Univ, Coll Phys & Surg, Dept Psychiat, New York, NY USA
[6] Columbia Univ, Coll Phys & Surg, Dept Radiol, New York, NY USA
[7] NYU, Med Ctr, Dept Psychiat, New York, NY 10016 USA
[8] Med Univ S Carolina, Dept Psychiat, Charleston, SC 29425 USA
[9] Ralph H Johnson Vet Hosp, Charleston, SC USA
[10] Quintiles Inc, Res Triangle Pk, NC USA
[11] Univ Pittsburgh, Sch Med, Dept Psychiat, Pittsburgh, PA USA
[12] Univ Maryland, Sch Med, Dept Vet Affairs, Mental Hlth Serv Line, Baltimore, MD 21201 USA
[13] Univ Maryland, Sch Med, Dept Psychiat, Baltimore, MD 21201 USA
[14] Univ Minnesota, Sch Med, Dept Psychiat, Minneapolis, MN 55455 USA
[15] Univ Nebraska, Med Ctr, Dept Psychiat, Omaha, NE 68182 USA
[16] Univ Calif San Diego, Med Ctr, Dept Psychiat, La Jolla, CA 92093 USA
[17] Rush Presbyterian St Lukes Med Ctr, Dept Psychiat, Chicago, IL 60612 USA
[18] Massachusetts Gen Hosp, Dept Psychiat, Boston, MA 02114 USA
[19] Univ Toronto, Dept Psychiat, Toronto, ON, Canada
关键词
vagus nerve stimulation (VNS); major depressive disorder; bipolar disorder; treatment-resistant depression (TRD); clinical trial; efficacy; side effects;
D O I
10.1016/j.biopsych.2005.05.025
中图分类号
Q189 [神经科学];
学科分类号
071006 [神经生物学];
摘要
Background: Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. Methods: This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with noupsychotic major depressive disorder (n = 210) or nonpsycbotic, depressed phase, bipolar disorder (n = 25). in the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sbam VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (>= 50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD24]). Results: At 10-weeks, HRSD24 response rates were 15.2% for the active (n = 112) and 10.0% for the sham (n = 110)groups (p = .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology Self-Report (IDS-SR30), were 17.0% (active) and 7.3% (sham) (p = .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. Conclusions: This study did not yield definitive evidence of short-term efficacy\for adjunctive VNS in treatment-resistant depression.
引用
收藏
页码:347 / 354
页数:8
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