Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression.

Journal: Journal Of Affective Disorders
Published:
Abstract

Background: To evaluate the effectiveness of quetiapine extended release once daily in bipolar depression.

Methods: Double-blind, placebo-controlled study in acutely depressed adults with bipolar I or II disorder, with or without rapid cycling. Patients were randomized to 8 weeks of quetiapine extended release (XR) 300 mg daily monotherapy or placebo. The primary outcome measure was change from baseline to Week 8 in MADRS total score.

Results: Quetiapine XR 300 mg once daily (N=133) showed significantly greater improvement in depressive symptoms compared with placebo (N=137) from Week 1 (p<0.001) through to Week 8 (p<0.001). Mean change in MADRS total score at Week 8 was -17.4 in the quetiapine XR group and -11.9 in the placebo group (p<0.001). Response (>or=50 reduction in MADRS total score) and remission (MADRS total score

Conclusions: Fewer patients with bipolar II disorder included, only one fixed dose tested and the lack of an active comparator. Conclusions: Quetiapine XR (300 mg) once daily monotherapy was significantly more effective than placebo for treating episodes of depression in bipolar I disorder, throughout the 8-week study, with significance observed as early as Day 7. Adverse events were consistent with the known effects of quetiapine.

Authors
Trisha Suppes, Catherine Datto, Margaret Minkwitz, Arvid Nordenhem, Chris Walker, Denis Darko
Relevant Conditions

Bipolar Disorder (BPD)