title: Safety and efficacy of quetiapine in bipolar depression.
abstract: OBJECTIVE
  To review the clinical data investigating the efficacy and safety of quetiapine in bipolar depression.
  
  
  METHODS
  Searches of MEDLINE and PubMed (1977-July 2009) were conducted using the key words quetiapine and bipolar depression. The references of literature found were cross-referenced. The pharmaceutical company that produces quetiapine was contacted to obtain the posters for the EMBOLDEN I and EMBOLDEN II trials.
  
  
  METHODS
  Only double-blind, placebo-controlled trials were included for review, as well as any subanalyses of the literature that matched this criterion.
  
  
  RESULTS
  There was a total of 5 double-blind, placebo-controlled trials and 5 subanalyses reviewed. The results of these data demonstrated quetiapine's efficacy in the treatment of depressive phases of bipolar disorder, including statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS). In the trials reviewed in this article, the change in MADRS scores ranged from -15.4 to -16.94 within the quetiapine groups, and from -10.26 to -11.93 in the placebo groups. There were also statistically significant improvements in the Hamilton Anxiety Rating Scale, the Short Form of the Quality of Life Enjoyment and Satisfaction Questionnaire, the Pittsburgh Sleep Quality Index, and the Sheehan Disability Scale. All of these trials had a duration of 8 weeks and therefore cannot be applied to the long-term use of quetiapine in bipolar depression. The most common adverse events were sedation, somnolence, and dry mouth. The overall dropout rates for the trials reviewed ranged from 24% to 47%.
  
  
  CONCLUSIONS
  Based on the literature reviewed here, quetiapine appears to be a safe and efficacious short-term treatment option for bipolar depression. Patients with bipolar type I showed greater improvement on the MADRS than those with bipolar type II. Patients with a rapid-cycling disease course showed an improvement in depressive symptoms, regardless of bipolar type.
authors.affiliation: Englewood Hospital and Medical Center, Englewood, NJ, USA.
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Bogart
authors.forename: Benjamin
authors.initials: B
authors.lastname: Chavez
mesh_terms: D001714:Bipolar Disorder / Q000188:drug therapy* / Q000378:metabolism / Q000523:psychology*; D002986:Clinical Trials as Topic / Q000379:methods; D003987:Dibenzothiazepines / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D011569:Psychiatric Status Rating Scales; D000069348:Quetiapine Fumarate; D012893:Sleep Wake Disorders / Q000139:chemically induced / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate