Supported by funding from AstraZeneca Pharmaceuticals LP.
In Volume 10, Supplement 1, February 2008, this Abstract was omitted from the Poster Session. The correct citation for the Abstract is Bipolar Disord 2008; 10 (Suppl. 1). We apologize for this error.
A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH ACUTE AND CONTINUATION PHASE OF QUETIAPINE AND LITHIUM IN ADULTS WITH BIPOLAR DEPRESSION (EMBOLDEN I)
AH Younga, A Carlssonb, B Olaussonb, B Paulssonb and M Brecherc
aDepartment of Psychiatry, Institute of Mental Health, The University of British Columbia, Vancouver, Canada, bAstraZeneca, Södertälje, Sweden, cAstraZeneca Pharmaceuticals LP, Wilmington, DE, USA
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: A total of 802 patients (499 bipolar I, 303 bipolar II) were randomized to quetiapine 300 mg/day (n = 265), quetiapine 600 mg/day (n = 268), lithium 600 mg/day (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 26–52-week continuation phase of quetiapine (300 mg/day or 600 mg/day) or placebo. Patients on lithium received 300 mg/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 300 mg/day), −16.10 (quetiapine 600 mg/day), −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 600 mg/day 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 (300 mg/day or 600 mg/day) 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.