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.