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Quetiapine, a novel antipsychotic: experience in elderly patients with psychotic disorders. Seroquel Trial 48 Study
D Q McManus1, L A Arvanitis, B B Kowalcyk
1Department of Neurology, Southern Illinois University, School of Medicine, Springfield 62794-9637, USA.
Background:
This uncontrolled trial examines the safety and effects of quetiapine, a new atypical antipsychotic, in elderly patients with psychotic disorders.
Method:
This is an ongoing, multicenter, open-label, 52-week trial of quetiapine in men and women at least 65 years old with DSM-IV psychotic disorders. Patients received quetiapine, 25 to 800 mg/day. Assessments included the 18-item Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impressions scale (CGI), the Simpson-Angus Neurologic Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS).
Results:
An interim analysis was performed at 12 weeks with results from 151 patients. The median total daily dose was 100 mg/day. The most common adverse events were somnolence (32%), dizziness (14%), postural hypotension (13%), and agitation (11%). Extrapyramidal symptom adverse events occurred in 6% of patients. Mean Simpson-Angus Scale total score showed significant (p<.0001) improvement at endpoint; there were no changes in AIMS scores. BPRS total and CGI-Severity of Illness scores showed significant (p<.0001 and p<.01, respectively) improvement at endpoint. No clinically important effects were reported for hematologic or liver function test variables; small changes in mean free levorotatory thyroxine (T4) levels were not associated with substantial changes in mean thyroid-stimulating hormone concentration. Mean corrected QT interval (QTc) was unchanged, but a slight increase in mean heart rate was noted.
Conclusion:
Quetiapine was well tolerated in a nonrandomized study of elderly patients and was associated with improvement in symptoms.