Abstract：
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 nonpsychotic major depressive disorder (n = 210) or nonpsychotic, 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 sham 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 [HRSD(24)]). RESULTS:At 10-weeks, HRSD(24) 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-SR(30)), 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.
journal_name
Biol Psychiatryjournal_title
Biological psychiatryauthors
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 RGdoi
10.1016/j.biopsych.2005.05.025subject
Has Abstractpub_date
2005-09-01 00:00:00pages
347-54issue
5eissn
0006-3223issn
1873-2402pii
S0006-3223(05)00620-7journal_volume
58pub_type
临床试验,杂志文章,随机对照试验abstract：BACKGROUND:Pediatric Bipolar Disorder (BD) has been associated with a number of neurocognitive deficits not dissimilar to ADHD. This study compared neuropsychological profiles of 4 groups of adolescents (14-17 years): 41 Normal Controls (NC), 30 ADHD, 12 BD and 12 combined (BD+ADHD). METHODS:Participants were identifi...
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