Hostname: page-component-848d4c4894-r5zm4 Total loading time: 0 Render date: 2024-07-07T08:12:26.642Z Has data issue: false hasContentIssue false

P0160 - A double-blind, placebo-controlled study with acute and continuation phase of Quetiapine and Lithium in adults with bipolar depression (Embolden I)

Published online by Cambridge University Press:  16 April 2020

A.H. Young
Affiliation:
Department of Psychiatry, Institute of Mental Health, The University of British Columbia, Vancouver, BC, Canada
A. Carlsson
Affiliation:
AstraZeneca, Sodertalje, Sweden
B. Olausson
Affiliation:
AstraZeneca, Sodertalje, Sweden
B. Paulsson
Affiliation:
AstraZeneca, Sodertalje, Sweden
M. Brecher
Affiliation:
AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA

Abstract

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.
Background and Aims:

Evaluate the efficacy and tolerability of quetiapine and lithium monotherapy for major depressive episodes in bipolar disorder during an acute 8-week period and up to 52-week continuation phase.

Methods:

802 patients (499 bipolar I, 303 bipolar II) were randomized to quetiapine 300mg/d (n=265), quetiapine 600mg/d (n=268), lithium 600mg/d (n=136), or placebo (n=133) for 8 weeks. Primary endpoint was change from baseline to 8 weeks in MADRS total score. After 8 weeks, patients with MADRS ≤12 and YMRS ≤12 entered a 26- to 52-week continuation phase of quetiapine (300mg/d or 600mg/d) or placebo. Patients on lithium received 300mg/day of quetiapine (results of continuation phase not included here and to be presented separately).

Results:

LSM MADRS score change at 8 weeks was -15.36 (quetiapine 300mg/d), -16.10 (quetiapine 600mg/d), -13.60 (lithium), and -11.81 (placebo; P<0.001 for both quetiapine doses, P=0.123 for lithium, versus placebo; LOCF ANCOVA). Quetiapine (both doses)-treated, but not lithium-treated, patients showed significantly greater improvements (P≤0.05) in MADRS response and remission rates, HAM-D, CGI-BP-S, CGI-BP-Change, and HAM-A at Week 8 versus placebo; MADRS item 10 (suicidal thoughts) improved with quetiapine 600mg/d versus placebo (P=0.013). Most common adverse events considered drug-related included somnolence, dry mouth, and dizziness with quetiapine (both doses) and nausea with lithium.

Conclusions:

Quetiapine (300mg/d or 600mg/d) was more effective than placebo for the treatment of acute depressive episodes in bipolar I and bipolar II disorder. Quetiapine treatment was generally well tolerated.

Supported by funding from AstraZeneca Pharmaceuticals LP.

Type
Poster Session II: Bipolar Disorders
Copyright
Copyright © European Psychiatric Association 2008
Submit a response

Comments

No Comments have been published for this article.