Quetiapine, a novel antipsychotic: experience in elderly patients with psychotic disorders. Seroquel Trial 48 Study Group.
BACKGROUND
This uncontrolled trial examines the safety and effects of quetiapine, a new atypical antipsychotic, in elderly patients with psychotic disorders.


METHODS
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.


CONCLUSIONS
Quetiapine was well tolerated in a nonrandomized study of elderly patients and was associated with improvement in symptoms.
McManus
D Q
DQ
Department of Neurology, Southern Illinois University, School of Medicine, Springfield 62794-9637, USA.
Arvanitis
L A
LA
Kowalcyk
B B
BB
D000368:Aged; D000369:Aged, 80 and over; D017109:Akathisia, Drug-Induced / Q000209:etiology; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010054:Brief Psychiatric Rating Scale / Q000706:statistics & numerical data; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007024:Hypotension, Orthostatic / Q000139:chemically induced; D008297:Male; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011618:Psychotic Disorders / Q000188:drug therapy* / Q000523:psychology; D000069348:Quetiapine Fumarate; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate