title: [The pharmacological treatment of bipolar disorder: a systematic and critical review of the methodological aspects of modern clinical trials].
abstract: OBJECTIVE
  To review systematically the main clinical trials on the pharmacological treatment of bipolar disorder and to make a critical analysis of their methodological aspects.
  
  
  METHODS
  A search in Medline, ISI and PsycINFO databases was conducted, using the following search terms: "bipolar", "randomized", "placebo" e "controlled". Randomized, double-blind, placebo-controlled clinical trials on the pharmacological treatment of bipolar disorder were selected. Besides, according to our criteria, samples had to consist of at least 100 patients and experimental drug had to be used as monotherapy.
  
  
  RESULTS
  34 articles met our selection criteria. All drugs currently indicated for mania, bipolar depression and maintenance treatment of bipolar disorder were more effective than placebo in at least one clinical trial. However, these studies had highly selected samples, high dropout rates and low response rates.
  
  
  CONCLUSIONS
  Modern clinical trials on pharmacological treatment of bipolar disorder have important methodological limitations. So, their results should be taken with caution.
authors.affiliation: Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil. echeniaux@gmail.com
authors.forename: Elie
authors.initials: E
authors.lastname: Cheniaux
mesh_terms: D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents