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Aripiprazole in the maintenance treatment of bipolar disorder: A critical review of the evidence and its dissemination into the scientific literature
PLoS Medicine, 05/06/2011

Tsai AC et al. – A single trial by Keck et al. represents the entirety of the literature on the use of aripiprazole for the maintenance treatment of bipolar disorder. Although careful review identifies four critical limitations to the trial's interpretation and overall utility, the trial has been uncritically cited in the subsequent scientific literature.

Methods

  • Systematically searched multiple databases to identify double-blind, randomized controlled trials of aripiprazole for maintenance treatment of bipolar disorder while excluding other types of studies, such as open-label, acute, and adjunctive studies
  • Used citation search to identify articles that cited these trials and rated quality of their citations

Results
  • Our evidence search protocol identified only two publications, both describing the results of a single trial conducted by Keck et al., which met criteria for inclusion in this review
  • Describe 4 issues that limit interpretation of that trial as supporting use of aripiprazole for bipolar maintenance: (1) insufficient duration to demonstrate maintenance efficacy; (2) limited generalizability due to its enriched sample; (3) possible conflation of iatrogenic adverse effects of abrupt medication discontinuation with beneficial effects of treatment; and (4) a low overall completion rate
  • Citation search protocol yielded 80 publications that cited Keck et al. trial in discussing use of aripiprazole for bipolar maintenance
  • 24 (30%) mentioned AEs reported and 4 (5%) mentioned study limitations

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