title: A randomised, placebo-controlled 52-week trial of continued quetiapine treatment in recently depressed patients with bipolar I and bipolar II disorder.
abstract: OBJECTIVE
  To examine the longer-term efficacy of quetiapine monotherapy in bipolar depression in a preplanned pooling of data from the EMBOLDEN I and II studies.
  
  
  METHODS
  Patients (N = 584) with bipolar I or II disorder (most recent episode: depressed) who achieved remission after 8 weeks of treatment with quetiapine (300 or 600 mg/day) were randomised to the same quetiapine dose or placebo for 26-52 weeks or until mood event recurrence.
  
  
  RESULTS
  The risk for recurrence of a mood event was significantly lower with quetiapine than placebo (HR 0.51 (95% CI: 0.38-0.69); < 0.001). Quetiapine was associated with a lower risk for recurrence of depressive events (HR 0.43 (95% CI: 0.30-0.62); P < 0.001) but recurrence of manic/hypomanic events was not significantly reduced (HR 0.75 (95% CI: 0.45-1.24; P = 0.263). There was a lower risk of recurrence of mood events in bipolar I (HR 0.58 (95% CI: 0.41-0.82), P = 0.002) and bipolar II patients (HR 0.33 (95% CI: 0.18-0.60), P < 0.001). Discontinuation rates due to adverse events were 4.3, 4.0 and 1.7% for quetiapine 300 mg/day, 600 mg/day and placebo, respectively. Safety data, including changes in lipid and glucose parameters, were consistent with the recognized profile of quetiapine.
  
  
  CONCLUSIONS
  The efficacy of quetiapine monotherapy in bipolar depression is maintained during continued treatment for 26-52 weeks. Quetiapine was generally well tolerated.
authors.affiliation: Imperial College , London , UK.
authors.forename: Allan H
authors.initials: AH
authors.lastname: Young
authors.forename: Susan L
authors.initials: SL
authors.lastname: McElroy
authors.forename: Bengt
authors.initials: B
authors.lastname: Olausson
authors.forename: Björn
authors.initials: B
authors.lastname: Paulsson
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001714:Bipolar Disorder / Q000145:classification / Q000188:drug therapy*; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008297:Male; D010919:Placebos; D000069348:Quetiapine Fumarate; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D010919:Placebos; D000069348:Quetiapine Fumarate