Authors: Jones M and Huizar K.
Title: Randomized, double-blind, controlled data on the treatment of mania with quetiapine.
Reference: Presented at the ICBP, Sydney, Australia 2004. [Congress poster]
Purpose: To evaluate the efficacy and safety of quetiapine monotherapy for the treatment of mania in a large cohort of patients with bipolar disorder.
Study design: Combined analysis of two randomized, double-blinded, placebo-controlled trials.
Follow up: 21 weeks.
Patients: 604 patients (299 quetiapine, 98 lithium, 99 haloperidol, and 198 placebo).
Treatment: Quetiapine titrated up to a maximum of 800 mg/day depending on response, lithium adjusted to a serum level of 0.6–1.4 mEq/L, and haloperidol titrated to a maximum of 8 mg/day.
Results: A significant improvement in YMRS score was observed with quetiapine treatment from day 4 onwards. Lithium and haloperidol were similar to quetiapine in all efficacy measures. Common adverse events observed in patients receiving quetiapine were insomnia, dry mouth, and somnolence (with the latter being the most common adverse event). High rates of EPS and tremor were observed with haloperidol and lithium, but not with quetiapine.