Background: This uncontrolled trial examines the safety and effects of quet
iapine, a new atypical antipsychotic, in elderly patients with psychotic di
sorders.
Method: This is an ongoing, multicenter, open-label, 52-week trial of queti
apine in men and women at least 65 years old with DSM-IV psychotic disorder
s. Patients received quetiapine, 25 to 800 mg/day. Assessments included the
Is-item Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impress
ions scale (CGI), the Simpson-Angus Neurologic Rating Scale, and the Abnorm
al Involuntary Movement Scale (AIMS).
Results: An interim analysis was performed at 12 weeks with results from 15
1 patients. The median total daily dose was 100 mg/day. The most common adv
erse events were somnolence (32%), dizziness (14%), postural hypotension (1
3%), 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. BP
RS total and CGI-Severity of Illness scores showed significant (p < .0001 a
nd p < .01, respectively) improve ment at endpoint. No clinically important
effects were reported for hematologic or liver function test variables; sm
all changes in mean free levorotatory thyroxine (T-4) levels were not assoc
iated with substantial changes in mean thyroid-stimulating hormone concentr
ation. Mean corrected QT interval (QTc) was unchanged, but a slight increas
e in mean heart rate was noted.
Conclusion: Quetiapine was well tolerated in a nonrandomized study of elder
ly patients and was associated with improvement in symptoms.