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| |  APA MEETING: Seroquel Appears To Work In Some Bipolar And Schizoaffective Patients WASHINGTON, DC -- May 20, 1999 -- Research presented at the American Psychiatric Association's annual meeting suggests Zeneca Pharmaceuticals' Seroquel(R) (quetiapine fumarate) Tablets may be an effective treatment for bipolar disorder and schizoaffective disorder. Interim results from an open-label trial of the atypical antipsychotic in neuroleptic-dependent patients with bipolar (manic depression) and schizoaffective disorder and cases from an ongoing trial of patients with psychotic depression show the drug may be effective in these three patient populations. Patients with schizoaffective disorder have a greater risk of suffering adverse neurologic effects from treatment compared with patients with schizophrenia and patients with bipolar disorder may need treatment with antipsychotic medication either intermittently or long term. Researchers assessed the efficacy and tolerability of Seroquel in neuroleptic-dependent patients with these disorders in a prospective, 12-week, open-label study. Interim results demonstrate that bipolar and schizoaffective disorder patients improved on Seroquel. Researchers gave add-on Seroquel therapy to patients (nine with bipolar disorder and seven with schizoaffective disorder) who required both mood stabilising and neuroleptic medication for at least six months. Other antipsychotic medication gradually was discontinued. Overall, patients showed significant improvement in the Brief Psychiatric Rating Scales, Youth Mania Rating Scale and Hamilton Depression Scale -- all common measures of psychological health. These data demonstrate that Seroquel may be an effective antipsychotic medication in neuroleptic-dependent patients with serious mood disorders. Researchers say these results should be explored in large controlled trials. Patients with psychotic depression also are an important population who can be helped by antipsychotic medications. Physicians typically prescribe an antidepressant and antipsychotic combination therapy for these patients. However, researchers believe that atypical antipsychotics alone may effectively treat psychotic depression without the addition of antidepressants. To study this theory, an ongoing open-label trial has been initiated to investigate the efficacy of Seroquel in psychotic depression. Researchers are enrolling patients meeting DSM-IV criteria for psychotic depression. The researchers are prescribing increasing doses of Seroquel over a six-week period up to between 400 mg and 600 mg per day in split doses. Patients still are being enrolled in this study and researchers say the topic should be explored in large controlled trials. Clinical trials with Seroquel have demonstrated efficacy in treating the positive and negative symptoms of schizophrenia and were no different from placebo across the clinical dose range in the incidence of EPS, including rigidity and difficulty starting and stopping movement, or elevation of plasma prolactin levels. In addition, studies have shown that Seroquel exhibits a low incidence of hormonal, reproductive (sexual dysfunction) and anticholinergic side effects (dry mouth, constipation). In clinical trials, efficacy was demonstrated in a dose range of 150 mg/day to 750 mg/day. An initial target dose range of 300-400 mg can be given in two divided doses daily. The efficacy of Seroquel, as well as the atypical profile which distinguishes the compound from standard antipsychotic agents, is supported by several placebo- and comparator-controlled phase II and III clinical trials in patients hospitalised for acute exacerbation of chronic or subchronic schizophrenia. Seroquel was well tolerated in more than 4,000 male and female patients 18 years and older. Seroquel is comparable to placebo with regard to EPS. No blood monitoring is required. As with other agents in its class, the labelling for Seroquel Tablets includes a warning relative to a rare condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents) and neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Precautions include orthostatic hypotension and the risk of cataract development. As with other antipsychotics, Seroquel therapy should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold. The most common adverse events exhibited across placebo-controlled trials included headache (19 percent), somnolence (18 percent) and dizziness (10 percent) and the majority of events rated were mild or moderate. The safety and effectiveness of Seroquel in pediatric patients (less than 18 years of age) have not been established.
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