Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

Phase 3 Completed 361 enrolled AstraZeneca

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Timeline

Start: 2010-12
Primary completion: 2012-11
Completion: 2012-11

Outcome

Met primary endpoint

paper The mean change in the MADRS total score was significantly greater in the quetiapine XR group than in the placebo group (-19.00 ± 7.88 vs. -16.20 ± 9.32; p = 0.004). PMID 26911380 ↗

registry p = 0.004; Least Square Mean difference vs Placebo -3.22 (95% CI -5.39 to -1.04) NCT01256177 ↗

Publications

Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quetiapine	Small molecule	300 mg	Oral