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Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies

Allan H Young113*, Joseph R Calabrese2, Urban Gustafsson3, Michael Berk1011124, Susan L McElroy56, Michael E Thase7, Trisha Suppes8 and Willie Earley9

Author Affiliations

1 Department of Psychiatry, Imperial College, London SW7 2AZ, UK

2 University Hospitals Case Medical Center, Case Western Reserve University, Cleveland OH 44106, USA

3 Formerly AstraZeneca R&D, Södertälje 151 85, Sweden

4 School of Medicine, Deakin University, Deakin 3217, Australia

5 Lindner Center of HOPE, Mason, OH 45040, USA

6 University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA

7 Department of Psychiatry, University of Pennsylvania School of Medicine, Western Pennsylvania, PA 19104, USA

8 Department of Psychiatry and Behavioral Sciences, Stanford Medical Center and VA Palo Alto Health Care System, Palo Alto, CA 94304, USA

9 Formerly AstraZeneca Pharmaceuticals LP, Wilmington, DE 19803, USA

10 Orygen Youth Health Research Centre, Centre for Youth Mental Health, Parkville, VIC 3052, Australia

11 The Mental Health Research Institute of Victoria, Parkville, VIC 3052, Australia

12 Department of Psychiatry, Melbourne University, Parkville, VIC 3052, Australia

13 Centre for Affective Disorders, Institute of Psychiatry, King’s College, London WC2R 2LS, UK

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International Journal of Bipolar Disorders 2013, 1:10  doi:10.1186/2194-7511-1-10

Published: 4 July 2013

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.

Results and discussion

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.

Keywords:
Bipolar II depression; Efficacy; Monotherapy; Quetiapine; Tolerability