The efficacy of quetiapine monotherapy in bipolar II depression: combined data from the BOLDER and EMBOLDEN studies

  • Dr Allan Young, University of British Columbia, Canada
  • Dr Joseph Calabrese, University Hospitals Case Medical Center, Case Western Reserve University, United States
  • Dr Urban Gustafsson, AstraZeneca R&D, Sweden
  • Dr Björn Paulsson, AstraZeneca R&D, Sweden
  • Dr Gin Malhi, CADE Clinic, and University of Sydney
  • Dr David Bond, University of British Columbia, Canada
  • Dr Nicol Ferrier, Institute of Neuroscience, Newcastle University

Objectives: Combined data are presented from 4 PBO-controlled studies (BOLDER I and II; EMBOLDEN I and II) that evaluated the efficacy of QTP monotherapy in patients with bipolar II disorder.
Methods: All studies included an 8-week, double-blind treatment phase in which patients were assigned to QTP 300 mg/d, 600 mg/d, or PBO. The EMBOLDEN studies also included a 26–52-week continuation phase, in which patients achieving remission continued on the same dose of QTP or switched to PBO. Outcome measures included change from baseline in MADRS total score at Week 8 and time to recurrence of any predefined mood event (EMBOLDEN only). MADRS response and remission rates and HAM-D and HAM-A were also assessed.
Results: Improvements in MADRS total scores from baseline to Week 8 were significantly greater with QTP 300 mg/d and 600 mg/d (-15.58 and -14.88; P<0.001) compared with PBO (-11.61). MADRS effect sizes were 0.44 and 0.47 for QTP 300 mg/d and 600 mg/d (P<0.0001 vs PBO). In the EMBOLDEN studies, continued treatment with both doses of QTP significantly reduced the risk of recurrence of a mood event versus PBO (HRs, 0.47 [95% CI, 0.25-0.92] and 0.18 [95% CI, 0.07-0.51]; P≤0.05 vs PBO). Common AEs associated with QTP included dry mouth, somnolence, sedation, dizziness, and headache. Rates of mania/hypomania were similar for QTP and PBO.
Conclusions: QTP monotherapy demonstrated significant efficacy, compared with PBO, in the treatment of bipolar II depression. QTP was generally well tolerated in all 4 studies.

Supported by funding from AstraZeneca Pharmaceuticals LP.