You are not logged in.
Openly accessible

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

Young, Allen H, Calabrese, Joseph R, Gustafsson, Urban, Berk, Michael, McElroy, Susan L, Thase, Michael E, Suppes, Trisha and Earley, Willie 2013, Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies, International journal of bipolar disorders, vol. 1, pp. 1-12, doi: 10.1186/2194-7511-1-10.

Attached Files
Name Description MIMEType Size Downloads
berk-quetiapinemonotherapy-2013.pdf Published version application/pdf 512.70KB 4

Title Quetiapine monotherapy in bipolar II depression: combined data from four large, randomized studies
Author(s) Young, Allen H
Calabrese, Joseph R
Gustafsson, Urban
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
McElroy, Susan L
Thase, Michael E
Suppes, Trisha
Earley, Willie
Journal name International journal of bipolar disorders
Volume number 1
Article ID 10
Start page 1
End page 12
Total pages 12
Publisher SpringerOpen
Place of publication London, Eng.
Publication date 2013
ISSN 2194-7511
Keyword(s) Bipolar II depression
Efficacy
Monotherapy
Quetiapine
Tolerability
Summary 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.
Language eng
DOI 10.1186/2194-7511-1-10
Field of Research 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Socio Economic Objective 970111 Expanding Knowledge in the Medical and Health Sciences
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2013, Young et al.
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30069234

Document type: Journal Article
Collections: School of Medicine
Open Access Collection
Connect to link resolver
 
Unless expressly stated otherwise, the copyright for items in DRO is owned by the author, with all rights reserved.

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.

Versions
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 0 times in TR Web of Science
Scopus Citation Count Cited 0 times in Scopus
Google Scholar Search Google Scholar
Access Statistics: 24 Abstract Views, 6 File Downloads  -  Detailed Statistics
Created: Tue, 10 Feb 2015, 08:44:41 EST

Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.