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ICBD: Seroquel (Quetiapine Fumarate) Promising for Patients With Bipolar Disorder and Cocaine Dependency PITTSBURGH, PA -- June 15, 2001 -- Research being presented today at the Fourth International Conference on Bipolar Disorder, suggest that Seroquel® (quetiapine fumarate) Tablets improved both depressive and manic symptoms, and significantly reduced cocaine cravings, in patients who have bipolar disorder and cocaine dependence, also referred to as "Dual-diagnosis" patients(1). Seroquel, a product of AstraZeneca, is indicated for the treatment of schizophrenia in adults. More than 60 percent of individuals with bipolar disorder also suffer from alcoholism or drug-abuse problems(2). Several studies have shown that patients who have bipolar disorder and a substance-abuse problem have more difficulties associated with the course of their mood disorder than do patients without a substance-abuse component(2). "Dual-diagnosis" patients, on average, first develop symptoms of bipolar disorder at a younger age than do patients without a substance-abuse problem, and in some studies they had more frequent hospitalizations(2). Substance abuse may worsen the course of bipolar disorder due to the direct effect of repeated drug use on the brain(2). "We are excited by the promising data showing that quetiapine both improves mood and significantly decreases drug use or cravings in patients with 'Dual-diagnosis,' said study co-investigator E. Sherwood Brown, Ph.D., M.D., Assistant Professor of Psychiatry, the University of Texas Southwestern Medical Center, Department of Psychiatry, Dallas, Texas. "Because bipolar disorder may be associated with the highest rates of substance abuse of any psychiatric illness, it's critical that further research is conducted on quetiapine treatment in this population. " Researchers evaluated the efficacy of Seroquel Tablets in a 12-week, open-label study involving patients (ages 18 to 65 years) who had bipolar disorder and cocaine dependence(1). The study involved 17 outpatients, 12 of whom completed at least four weeks of the study and eight who completed all 12 weeks, including 10 patients with bipolar I (full-blown manic and depressive episodes[2]) and two patients with bipolar II (developed depressive episodes and episodes of hypomania[2]) disorder(1). After an initial clinical interview, patients were placed on a flexible dosing schedule starting with Seroquel at doses ranging from 50 to 100 mg. Doses were titrated upward weekly(1). Efficacy was measured biweekly for 12 weeks through a variety of assessments(1). Psychiatric symptoms were evaluated using the Hamilton Depression Rating Scale (HDRS), Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS)(1). To assess cocaine cravings, a 10-item version of the Cocaine Craving Questionnaire (CCQ) was used. Drug use was determined by a self-report of the dollar amount spent on drugs in the past week and by the results of urine drug screens (UDS)(1). Improvement in efficacy measures was determined using a last observation carried forward analysis, which measured changes from baseline to study exit for patients who received at least four weeks of therapy. Both depressive and manic symptoms (ie. HDRS, YMRS, and BPRS scores) improved significantly from baseline, as did cocaine cravings as indicated by a reduction in the CCQ assessment(1). Eight subjects who completed all 12 weeks of the study had an 87 percent reduction in the amount of money spent on cocaine. The findings from this pilot study are promising and suggest that larger controlled studies of Seroquel in this patient population are needed(1). The efficacy and atypical profile of Seroquel is supported by several placebo- and comparator-controlled Phase II and Phase III clinical trials in patients with schizophrenia. In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400mg can be given in two divided doses daily. In studies supporting the approval of Seroquel, there were no differences from placebo across the clinical dose range in the incidence of extrapyramidal symptoms (EPS), including rigidity and difficulty starting and stopping movement, or in elevation of serum prolactin levels. In addition, studies have shown that Seroquel exhibits a low incidence of hormonal, reproductive system (sexual dysfunction), and anticholinergic side effects (dry mouth, constipation). As with other agents in its class, the labeling for Seroquel Tablets includes a warning relative to a condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and a rare condition known as neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeled precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. In pre-marketing studies, the most common adverse events associated with the use of Seroquel are dizziness (10 percent), postural hypotension (7 percent), dry mouth (7 percent), and dyspepsia (6 percent) and the majority of events are rated mild or moderate. The safety and effectiveness of Seroquel in pediatric patients have not been established. References: (1)Brown ES, Vejtek AV, Perantie DC, et al. Quetiapine in Patients with Bipolar Disorder and Cocaine Dependence. Poster presented at the Fourth International Conference on Bipolar Disorder in Pittsburgh, PA, June 14-16, 2001. (2)Mondimore F. Bipolar Disorder: A Guide for Patients and Families. Baltimore: Johns Hopkins University Press, 1999. SOURCE: AstraZeneca Related Links: Seroquel (quetiapine) and AstraZeneca. E-mail this page to a friend or colleague! To print, use this version