title: Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies.
abstract: BACKGROUND
  Despite being present in up to 1% of the population, few controlled trials have examined the efficacy of treatments for bipolar II depression. Pooled data are presented from four placebo-controlled studies (BOLDER I [5077US/0049] and II [D1447C00135]; EMBOLDEN I [D1447C00001] and II [D1447C00134]) that evaluated the efficacy of quetiapine monotherapy for depressive episodes in patients with bipolar II disorder.
  
  
  METHODS
  All studies included an 8-week, double-blind treatment phase in which patients were randomly assigned to treatment with quetiapine 300 mg/day, quetiapine 600 mg/day, or placebo. Outcome measures included the change from baseline in MADRS total score at week 8, effect sizes, and MADRS response and remission rates.
  
  
  CONCLUSIONS
  Improvements in mean MADRS total scores from baseline to week 8 were significantly greater with quetiapine 300 and 600 mg/day (-15.58 [n = 283] and -14.88 [n = 289]; p < 0.001) compared with placebo (-11.61 [n = 204]). The MADRS effect sizes were 0.44 for quetiapine 300 mg/day and 0.47 for 600 mg/day (p < 0.001 vs placebo). Significantly higher proportions of patients receiving quetiapine, at both doses, than placebo-treated patients achieved response and remission at week 8 (p < 0.01). Common adverse events associated with quetiapine (both doses) included dry mouth, somnolence, sedation, dizziness, and headache. Rates of mania and hypomania were similar for quetiapine and placebo. Quetiapine monotherapy demonstrated significant efficacy compared with placebo and was generally well tolerated in the treatment of bipolar II depression.
authors.affiliation: Department of Psychiatry, Imperial College, London, SW7 2AZ UK ; Centre for Affective Disorders, Institute of Psychiatry, King's College, London, WC2R 2LS UK.
authors.forename: Allan H
authors.initials: AH
authors.lastname: Young
authors.affiliation: University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH 44106 USA.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Calabrese
authors.affiliation: Formerly AstraZeneca R&D, Södertälje, 151 85 Sweden.
authors.forename: Urban
authors.initials: U
authors.lastname: Gustafsson
authors.affiliation: School of Medicine, Deakin University, Deakin, 3217 Australia ; Orygen Youth Health Research Centre, Centre for Youth Mental Health, Parkville, VIC, 3052 Australia ; The Mental Health Research Institute of Victoria, Parkville, VIC, 3052 Australia ; Department of Psychiatry, Melbourne University, Parkville, VIC, 3052 Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.affiliation: Lindner Center of HOPE, Mason, OH 45040 USA ; University of Cincinnati College of Medicine, Cincinnati, OH 45229 USA.
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.affiliation: Department of Psychiatry, University of Pennsylvania School of Medicine, Western Pennsylvania, PA 19104 USA.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford Medical Center and VA Palo Alto Health Care System, Palo Alto, CA 94304 USA.
authors.forename: Trisha
authors.initials: T
authors.lastname: Suppes
authors.affiliation: Formerly AstraZeneca Pharmaceuticals LP, Wilmington, DE 19803 USA.
authors.forename: Willie
authors.initials: W
authors.lastname: Earley
keywords: Bipolar II depression; Efficacy; Monotherapy; Quetiapine; Tolerability