Quetiapine monotherapy Authors: Paulsson B and Huizar K. Title: Quetiapine for the treatment of mania in bipolar disorder: a randomized, controlled trial. Reference: Presented at ICBP in Sydney, Australia 2004. [Congress poster] Purpose: To evaluate the efficacy and safety of quetiapine monotherapy for the treatment of mania associated with bipolar disorder. Study design: Randomized, double-blinded, placebo-controlled trial. Follow up: 21 days. Patients: 302 patients (107 quetiapine, 98 lithium, and 97 placebo). Treatment: Quetiapine titrated to a maximum of 800 mg/day depending on response, lithium adjusted to a serum level of 0.6-1.4 mEq/L, or placebo. Results: Quetiapine and lithium were similar in all efficacy measures. The most common adverse events with quetiapine were a dry mouth and somnolence. Lithium was associated with tremor and insomnia.