New Data Highlight Benefit Of SEROQUEL Monotherapy For Long-Term Treatment Of Bipolar Disorder

Results presented at the 21st European College of Neuropsychopharmacology (ECNP) congress in Barcelona, Spain have demonstrated the efficacy of SEROQUEL® (quetiapine fumarate) monotherapy for maintenance treatment in patients with bipolar disorder. Two EMBOLDEN (Efficacy of Monotherapy SEROQUEL in BipOLar DEpressioN) studies1,2 reported a significantly increased time to recurrence of a mood event compared with placebo in patients with bipolar I or II disorder and a recent major depressive episode. Additionally, in the clinical trial with the acronym SPaRCLe,3 patients with bipolar I disorder and a current manic, depressed or mixed episode who received SEROQUEL experienced a significantly longer time to recurrence of any mood event compared with patients receiving either lithium or placebo. SEROQUEL has already demonstrated efficacy for maintenance therapy of bipolar I disorder when used as adjunct therapy with lithium or divalproex; these new data indicate additional potential for SEROQUEL as a single therapy for these patients.


The EMBOLDEN studies are two similarly designed multicentre, randomised, double-blind comparisons of the efficacy and safety of SEROQUEL monotherapy (300 mg or 600 mg daily) with placebo in adult patients with bipolar I or II disorder. SEROQUEL monotherapy was significantly more effective than placebo for treating depressive episodes associated with bipolar disorder in the 8-week acute phase as measured by improvement in the Montgomery-Г…sberg Depression Rating Scale (MADRS) total score from baseline (p

Professor Alan Young of the Department of Psychiatry, University of British Columbia, Vancouver, Canada said: "Bipolar disorder is a chronic illness and patients need long-term treatment to help control their mood episodes. These new studies show that SEROQUEL monotherapy may delay the reappearance of depressed, manic or mixed events associated with bipolar disorder regardless of the type of mood event the patient is currently experiencing. This could be important for patients, because they are often faced with taking several different long-term medications to treat their illness."


Long-term treatment with SEROQUEL in the EMBOLDEN and SPaRCLe trials was generally well tolerated and adverse events were consistent with those reported in short term, placebo-controlled trials with SEROQUEL. The most common adverse events associated with SEROQUEL in the acute phase of the EMBOLDEN studies were somnolence, dry mouth and dizziness (EMBOLDEN I) and dry mouth, somnolence and sedation (EMBOLDEN II). The most commonly reported adverse events with SEROQUEL in the continuation phase included headache, nasopharyngitis, diarrhoea, somnolence and an increase in weight (EMBOLDEN I) and dry mouth, dizziness, sedation, headache and somnolence (EMBOLDEN II).


In the randomised phase of the SPaRCLE study, the most common adverse events associated with SEROQUEL were headache, somnolence and insomnia, and the most common adverse events associated with lithium were nausea, insomnia, headache and vomiting.


Other data presented at an AstraZeneca satellite symposium at ECNP highlighted the benefit of SEROQUEL when combined with a mood stabiliser (lithium or divalproex) for maintenance therapy of up to 104 weeks in patients with bipolar I disorder.4 Pooled results from two clinical studies indicated that patients treated with SEROQUEL plus lithium or divalproex had a risk reduction of 70% relative to those treated with placebo plus lithium or divalproex for time to recurrence of a mood event (hazard ratio = 0.30; 95% CI: 0.24-0.37; p