Efficacy and safety of quetiapine in the treatment of bipolar acute mania: a randomized, double-blind, lithium-controlled multicenter study

Abstract

Objective To evaluate the efficacy and safety of quetiapine fumarate as mono-therapy for acute mania in patients with bipolar disorder.Methods The study design was randomized,double blind,double dummy.lithium controlled.multicenter trial.Patients with bipolar disorder were hospitalized for the treatment of an acute manic episode according to the Chinese Classification of Mental Disorders 3rd edition criteria.and with the Young Mania Rating Scale(YMRS)total score≥20 were randomized to receive quetiapine(twice daily up to 800 mg/d)or lithium(twice daily up to 2000 mg/d).The primary endpoint was the change of YMRS total score from baseline to Day 28(last observation carried forward;LOCF).The safety was evaluated with the rate of adverse events(AEs),laboratory test and ECG.Results The ITTincluded 154 subjects.with 77 in each treatment group.Mean doses were 642.9 mg/d and 1377.7 mg/d for quetiapine and lithium respectively.Changes of YMRS total score from baseline to Day 28 in quetiapine and lithium group were-18.2 and-15.9,respectively.At Day 28,the response rate was significantly higher in quetiapine-treated patients(78%vs.60%;P=0.013).Quetiapine was well tolerated up to doses of 800 mg/d,and 78%of patients in quetiapine group and 69%in lithium group reported AEs.The most frequently reported AEs in quetiapine group were constipation(35%),dizziness(15%),and diarrhea (10%),and in lithium group were nausea(17%),constipation(13%),and vomiting(13%).Three subjects in lithium group but none in quetiapine group withdrew due to AEs.Conclusions The study resuhs support that quetiapine monotherapy is effective and well tolerated in the treatment of acute mania. Key words: Bipolar disorder; Lithium carbonate; Randomized controlled trials; Quetiapine